Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

• Sponsor: Stanford University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03330704
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Edema; Saline Solution, Hypertonic	Drug: 3% Sodium Chloride; Drug: 23.4% Sodium Chloride; Drug: 8.4% Sodium Bicarbonate	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
• Actual Study Start Date: Nov 28, 2017
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Therapy This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation.	Drug: 3% Sodium Chloride; 3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
Experimental: Balanced Therapy This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach	Drug: 23.4% Sodium Chloride; 23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure; Drug: 8.4% Sodium Bicarbonate; 8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure

Outcome Measures

Primary Outcome Measures

1. Total volume of intravenous hypertonic fluid administered to the patient [The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment]

   Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.

Secondary Outcome Measures

1. Urine output [Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment]

   Urine output will be collected and measured quantitatively in milliliter units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to consent

• 18 years or older

• English speaking

• Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration

Exclusion Criteria:

• Fails to consent

• < 18 years old

• Hypertonic therapy not indicated

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Hospital	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Tim Angelotti, MD, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. Review.
• Erdman MJ, Riha H, Bode L, Chang JJ, Jones GM. Predictors of Acute Kidney Injury in Neurocritical Care Patients Receiving Continuous Hypertonic Saline. Neurohospitalist. 2017 Jan;7(1):9-14. doi: 10.1177/1941874416665744. Epub 2016 Aug 29.
• Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium acetate as a replacement for sodium bicarbonate in medical toxicology: a review. J Med Toxicol. 2013 Sep;9(3):250-4. doi: 10.1007/s13181-013-0304-0. Review.
• Toung TJ, Nyquist P, Mirski MA. Effect of hypertonic saline concentration on cerebral and visceral organ water in an uninjured rodent model. Crit Care Med. 2008 Jan;36(1):256-61.
• Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35.

• Responsible Party: Tim Angelotti, Associate Professor of Anesthesiology, Stanford University
• ClinicalTrials.gov Identifier: NCT03330704
• Other Study ID Numbers: IRB-43653
• First Posted: Nov 6, 2017
• Last Update Posted: Mar 19, 2020
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Brain Edema

Study Results

No Results Posted as of Mar 19, 2020