Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
Study Details
Study Description
Brief Summary
The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management.
Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Detailed Description
This is a single-center, open-label, safety and tolerability study. Based on findings in the literature from both animal research and clinical observations with ICH (intracerebral hemorrhage) associated with TBI (traumatic brain injury), this study will begin to look at the safety, tolerability, as well as potential effectiveness, of conivaptan to reduce CE (cerebral edema) in patients with non-traumatic ICH.
The seven patients in this study will receive 40mg/day of the study medication conivaptan. In this early phase study, our focus will be to assess the safety and tolerability of this medication. The available clinical data on conivaptan in the neurocritical care population suggest the potential harm is negligible. Data in TBI patients demonstrate conivaptan is safe and well tolerated using a single dose (20mg) to increase Na+ in a controlled fashion to reduce ICP. Previous work has demonstrated the safety and tolerability of conivaptan, in doses ranging from 20-80mg/day, in the neurocritical care population. Conivaptan has been demonstrated to be safe and effective in lowering ICP, and increasing serum sodium, in the neurocritical care population. Also noted have been improvements in cerebral perfusion pressure (CPP) and stable blood pressure, and a prolonged reduction in ICP. Finally, the method of intermittent bolus dosing of conivaptan is equally effective in raising and maintaining serum sodium in the neurocritical care population as continuous infusion, with potentially less risk of adverse reactions including phlebitis.
Conivaptan, a non-selective Arginine-Vasopressin (AVP) V1A/V2 antagonist that reduces aquaporin 4 production and promotes aquaresis, is approved for the treatment of euvolemic and hypervolemic hyponatremia. The exact cause of the observed reduction in ICP with conivaptan is uncertain. However, the mechanism most likely represents a combination of an acute pure aquaresis, removing free water from brain tissue, and a sustained down regulation of aquaporin 4 to abate/slow development of CE. The V2 antagonism of conivaptan promotes free water loss, and the V1 antagonism may improve cerebral blood flow (CBF) and reduce blood brain barrier permeability. Notably, serum sodium tends to correlate inversely with both ICP and CE. The early use of conivaptan could potentially be used clinically to reduce CE by these means.
It is with this in mind, the research team feels justified in pursuing this study with the hopes that the data obtained will lead to potential good and removal of harm in future patients with this devastating disease. Given the enormous costs of ICH, problems with current therapies, and variability in treatment, there is an urgent need to identify a therapy that has a better safety and effectiveness profile compared to the currently used agents. This study will use a dose (40mg/day) currently approved. Further, given that the primary purpose of the use of this medication in this study is not to correct hyponatremia, an investigational new drug (IND) application to the FDA was submitted, and the study was determined exempt.
Our central hypothesis is that through reductions in aquaporin-4 (AQP4) expression, the early use of conivaptan will reduce CE while also being safe to the patient. Our long term goal is to show that early use of conivaptan in ICH will reduce CE. If this reduction is possible, we hypothesize improved outcome and reducing the need for rescue therapies, ICU length of stay, and overall treatment cost will follow. However, more data is needed to evaluate the dosing and amount of drug. With respect to conivaptan's efficacy in correction of hyponatremia, a direct dose-response relationship exists. Further, this effect was more noted at milder degrees of hyponatremia.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Conivaptan Treatment Group All seven patients in this arm will receive conivaptan as described in Interventions. |
Drug: Conivaptan
Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.
The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Patient Tolerance of Conivaptan [Baseline to 168 hours post-enrollment]
The number of participants with abnormal seizure activity and/or abnormal lab values and/or increase in infection rate and/or any drug-related adverse events.
Secondary Outcome Measures
- In-hospital Mortality [Enrollment through hospital discharge, up to 3 weeks]
All-cause deaths during hospitalization
- Change in Cerebral Edema [Baseline to 168 hours post-enrollment]
Changes in cerebral edema (CE) as measured on CT. Goal is a -5 to -10% change in CE over time. Change will be measured both as absolute change in volume, calculated as the final volume minus the baseline volume measure and converted to a percentage of the baseline volume measure.
- Cost [Enrollment through hospital discharge, up to 3 weeks]
Cost as measured by length of stay in the neuro ICU.
- Cost [Baseline to 168 hours post-enrollment]
Cost as measured by: Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE. Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs). Number of patients requiring a ventilator.
- Modified Rankin Scale (mRS) Score [At discharge from ICU and from hospital, up to 3 weeks]
Modified Rankin Scale (0 to 6) at discharge from the hospital. A score of 0 indicates no disability and a score of 6 indicates the patient died. Functional independence is defined as a score of 2 or less.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >18 years old and < 80 years.
-
Diagnosis of primary ICH > 20 cc in volume.
-
Enrollment within 48 hours from initial symptoms.
-
Signed informed consent from the patient or obtained via their legally authorized representative (if the patient is not able to sign the informed consent themselves). The patient's decisional capacity to either provide or refuse consent will be determined using the Glasgow Coma Scale (GCS), which is being assessed at baseline and at 24 hours (+/-6hrs) after enrollment. A potential study participant with a GCS > 14 will be asked to provide their own initial study consent. A GCS ≤ 14 would indicate the need to pursue consent via legally authorized representative.
Exclusion Criteria:
-
Current need for renal replacement therapy (RRT).
-
Glomerular filtration rate (GFR) of <30 mL/minute at time of admission.
-
Participation in another study for ICH or intraventricular hemorrhage.
-
ICH related to infection, thrombolysis, subarachnoid hemorrhage, trauma or tumor.
-
Presence of HIV or active fungal infection that is known based on information in the electronic medical record (EMR).
-
Continued use of digoxin or amlodipine (as recommended by the manufacturer due to cytochrome P450 3A4 "CYP3A" inhibition).
-
Active hepatic failure as defined by aspartate aminotransferase (AST) >160 units/L and/or alanine transaminase (ALT) >180 units/L, or total bilirubin levels greater than four times normal levels (>4.8mg/dL).
-
Serum Na+> 145 mmol/L (admission labs or any time prior to recruitment/enrollment).
-
Unable to receive conivaptan based on contraindications indicated by the manufacturer.
-
Pregnant or lactating females.
-
Not expected to survive within 48 hours of admission, or a presumed diagnosis of brain death.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
Sponsors and Collaborators
- Jesse Corry
Investigators
- Principal Investigator: Jesse J Corry, MD, Allina Health
Study Documents (Full-Text)
More Information
Publications
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- Corry JJ, Varelas P, Abdelhak T, Morris S, Hawley M, Hawkins A, Jankowski M. Variable change in renal function by hypertonic saline. World J Crit Care Med. 2014 May 4;3(2):61-7. doi: 10.5492/wjccm.v3.i2.61. eCollection 2014 May 4.
- Corry JJ. The use of targeted temperature management for elevated intracranial pressure. Curr Neurol Neurosci Rep. 2014 Jun;14(6):453. doi: 10.1007/s11910-014-0453-9. Review.
- Corry JJ. Use of hypothermia in the intensive care unit. World J Crit Care Med. 2012 Aug 4;1(4):106-22. doi: 10.5492/wjccm.v1.i4.106. eCollection 2012 Aug 4. Review.
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- Diringer MN, Edwards DF. Admission to a neurologic/neurosurgical intensive care unit is associated with reduced mortality rate after intracerebral hemorrhage. Crit Care Med. 2001 Mar;29(3):635-40.
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- Galton C, Deem S, Yanez ND, Souter M, Chesnut R, Dagal A, Treggiari M. Open-label randomized trial of the safety and efficacy of a single dose conivaptan to raise serum sodium in patients with traumatic brain injury. Neurocrit Care. 2011 Jun;14(3):354-60. doi: 10.1007/s12028-011-9525-8.
- Gazitúa S, Scott JB, Chou CC, Haddy FJ. Effect of osmolarity on canine renal vascular resistance. Am J Physiol. 1969 Oct;217(4):1216-23.
- Gebel JM Jr, Jauch EC, Brott TG, Khoury J, Sauerbeck L, Salisbury S, Spilker J, Tomsick TA, Duldner J, Broderick JP. Natural history of perihematomal edema in patients with hyperacute spontaneous intracerebral hemorrhage. Stroke. 2002 Nov;33(11):2631-5.
- Grände PO, Romner B. Osmotherapy in brain edema: a questionable therapy. J Neurosurg Anesthesiol. 2012 Oct;24(4):407-12. doi: 10.1097/01.ana.0000419730.29492.8b. Review.
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- Kleindienst A, Fazzina G, Dunbar JG, Glisson R, Marmarou A. Protective effect of the V1a receptor antagonist SR49059 on brain edema formation following middle cerebral artery occlusion in the rat. Acta Neurochir Suppl. 2006;96:303-6.
- Li YH, Sun SQ. [Expression of aquaporin - 4 protein in brain from rats with hemorrhagic edema]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2003 Sep;15(9):538-41. Chinese.
- Liu X, Nakayama S, Amiry-Moghaddam M, Ottersen OP, Bhardwaj A. Arginine-vasopressin V1 but not V2 receptor antagonism modulates infarct volume, brain water content, and aquaporin-4 expression following experimental stroke. Neurocrit Care. 2010 Feb;12(1):124-31. doi: 10.1007/s12028-009-9277-x.
- Marik PE, Rivera R. Therapeutic effect of conivaptan bolus dosing in hyponatremic neurosurgical patients. Pharmacotherapy. 2013 Jan;33(1):51-5. doi: 10.1002/phar.1169.
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- Migliati ER, Amiry-Moghaddam M, Froehner SC, Adams ME, Ottersen OP, Bhardwaj A. Na(+)-K (+)-2Cl (-) cotransport inhibitor attenuates cerebral edema following experimental stroke via the perivascular pool of aquaporin-4. Neurocrit Care. 2010 Aug;13(1):123-31. doi: 10.1007/s12028-010-9376-8.
- Murphy T, Dhar R, Diringer M. Conivaptan bolus dosing for the correction of hyponatremia in the neurointensive care unit. Neurocrit Care. 2009;11(1):14-9. doi: 10.1007/s12028-008-9179-3. Epub 2009 Jan 4.
- Naidech AM, Paparello J, Liebling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61. doi: 10.1007/s12028-010-9379-5. Erratum in: Neurocrit Care. 2011 Aug;15(1):210. Leibling, Storm M [corrected to Liebling, Storm M].
- Nathan BR. Cerebral correlates of hyponatremia. Neurocrit Care. 2007;6(1):72-8.
- National PBM Drug Monograph. Conivaptan Hydrochloride Injection (Vaprisol). 2006. [Appendix 6]
- Nau R, Desel H, Lassek C, Thiel A, Schinschke S, Rössing R, Kolenda H, Prange HW. Slow elimination of mannitol from human cerebrospinal fluid. Eur J Clin Pharmacol. 1997;53(3-4):271-4.
- Onuoho A, Human T, Dringer MN, Dhar R. Predictors of the Response to a Bolus of Conivaptan in Patients with Acute Hyponatremia. Abstract Supplement. Volume 13. Neurocritical Care. 2010.
- Rosenberg GA, Scremin O, Estrada E, Kyner WT. Arginine vasopressin V1-antagonist and atrial natriuretic peptide reduce hemorrhagic brain edema in rats. Stroke. 1992 Dec;23(12):1767-73; discussion 1773-4. Erratum in: Stroke 1993 Jun;24(6):913.
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- Strandvik GF. Hypertonic saline in critical care: a review of the literature and guidelines for use in hypotensive states and raised intracranial pressure. Anaesthesia. 2009 Sep;64(9):990-1003. doi: 10.1111/j.1365-2044.2009.05986.x. Review.
- Sun Z, Zhao Z, Zhao S, Sheng Y, Zhao Z, Gao C, Li J, Liu X. Recombinant hirudin treatment modulates aquaporin-4 and aquaporin-9 expression after intracerebral hemorrhage in vivo. Mol Biol Rep. 2009 May;36(5):1119-27. doi: 10.1007/s11033-008-9287-3. Epub 2008 Jun 24.
- Szmydynger-Chodobska J, Chung I, Koźniewska E, Tran B, Harrington FJ, Duncan JA, Chodobski A. Increased expression of vasopressin v1a receptors after traumatic brain injury. J Neurotrauma. 2004 Aug;21(8):1090-102.
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- Venkatasubramanian C, Mlynash M, Finley-Caulfield A, Eyngorn I, Kalimuthu R, Snider RW, Wijman CA. Natural history of perihematomal edema after intracerebral hemorrhage measured by serial magnetic resonance imaging. Stroke. 2011 Jan;42(1):73-80. doi: 10.1161/STROKEAHA.110.590646. Epub 2010 Dec 16.
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- NSJC-1601
Study Results
Participant Flow
Recruitment Details | Participants were recruited based on physician referral at a single medical institution between March 1, 2017 and November 7, 2018. The first participant was enrolled on March 22, 2017 and the last participant was enrolled on November 7, 2018. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Period Title: Overall Study | |
STARTED | 7 |
COMPLETED | 7 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Overall Participants | 7 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
58.5
|
Sex: Female, Male (Count of Participants) | |
Female |
1
14.3%
|
Male |
6
85.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
7
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
2
28.6%
|
White |
5
71.4%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (Count of Participants) | |
United States |
7
100%
|
Outcome Measures
Title | Patient Tolerance of Conivaptan |
---|---|
Description | The number of participants with abnormal seizure activity and/or abnormal lab values and/or increase in infection rate and/or any drug-related adverse events. |
Time Frame | Baseline to 168 hours post-enrollment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
Abnormal Seizure Activity |
0
0%
|
Abnormal Lab Values |
0
0%
|
Infections |
1
14.3%
|
Drug-related Adverse Events |
0
0%
|
Title | In-hospital Mortality |
---|---|
Description | All-cause deaths during hospitalization |
Time Frame | Enrollment through hospital discharge, up to 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
Count of Participants [Participants] |
0
0%
|
Title | Change in Cerebral Edema |
---|---|
Description | Changes in cerebral edema (CE) as measured on CT. Goal is a -5 to -10% change in CE over time. Change will be measured both as absolute change in volume, calculated as the final volume minus the baseline volume measure and converted to a percentage of the baseline volume measure. |
Time Frame | Baseline to 168 hours post-enrollment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
Mean (Full Range) [percentage of change from baseline] |
-37.1
|
Title | Cost |
---|---|
Description | Cost as measured by length of stay in the neuro ICU. |
Time Frame | Enrollment through hospital discharge, up to 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
Mean (Full Range) [days] |
14.4
|
Title | Cost |
---|---|
Description | Cost as measured by: Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE. Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs). Number of patients requiring a ventilator. |
Time Frame | Baseline to 168 hours post-enrollment |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
EVD/bolt or surgical procedures |
0
0%
|
Lines or tracheostomy/PEG |
7
100%
|
Ventilator |
1
14.3%
|
Title | Modified Rankin Scale (mRS) Score |
---|---|
Description | Modified Rankin Scale (0 to 6) at discharge from the hospital. A score of 0 indicates no disability and a score of 6 indicates the patient died. Functional independence is defined as a score of 2 or less. |
Time Frame | At discharge from ICU and from hospital, up to 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Conivaptan Treatment Group |
---|---|
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. |
Measure Participants | 7 |
Median (Full Range) [score on a scale] |
5
|
Adverse Events
Time Frame | Throughout study participation. For each patient this extended from enrollment to 3 months after enrollment. | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Conivaptan Treatment Group | |
Arm/Group Description | All seven patients in this arm will receive conivaptan as described in Interventions. Conivaptan: Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen. The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line. | |
All Cause Mortality |
||
Conivaptan Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | |
Serious Adverse Events |
||
Conivaptan Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 7/7 (100%) | |
Infections and infestations | ||
Urinary Tract Infection | 1/7 (14.3%) | |
Nervous system disorders | ||
Intracranial Hemorrhage Expansion | 1/7 (14.3%) | |
Increase in Cerebral Edema | 1/7 (14.3%) | |
Respiratory, thoracic and mediastinal disorders | ||
Pulmonary Edema | 2/7 (28.6%) | |
Surgical and medical procedures | ||
Catheterization, Central Venous (PICC) | 7/7 (100%) | |
Tracheostomy | 3/7 (42.9%) | |
Gastostomy (PEG) | 2/7 (28.6%) | |
Vascular disorders | ||
Deep Vein Thrombosis | 2/7 (28.6%) | |
Other (Not Including Serious) Adverse Events |
||
Conivaptan Treatment Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Jesse Corry |
---|---|
Organization | Allina Health |
Phone | 651-241-6550 |
Jesse.Corry@allina.com |
- NSJC-1601