EUPHRATES: Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
Sponsor
Spectral Diagnostics (US) Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01046669
Collaborator
(none)
450
40
2
84
11.3
0.1
Study Details
Study Description
Brief Summary
To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock
Actual Study Start Date
:
Jun 1, 2010
Actual Primary Completion Date
:
Jul 1, 2016
Actual Study Completion Date
:
Jun 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Control Standard medical care for septic shock |
Other: Standard medical care for septic shock
Standard medical care for septic shock
|
| Experimental: Treatment Two (2) PMX cartridges will be administered approximately 24 hours apart plus standard medical care for septic shock |
Device: TORAYMYXIN PMX-20R (PMX cartridge)
TORAYMYXIN PMX-20R (PMX cartridge), Extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).
Other: Standard medical care for septic shock
Standard medical care for septic shock
|
Outcome Measures
Primary Outcome Measures
- Mortality [28 days]
Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Hypotension requiring vasopressor support
-
The subject must have received intravenous fluid resuscitation
-
Documented or suspected infection
-
Endotoxin Activity Assay ≥ 0.60 EAA units
-
Evidence of at least 1 new onset organ dysfunction
Exclusion Criteria:
-
Inability to achieve or maintain a minimum mean arterial pressure (MAP) of 65mmHg
-
Subject has end stage renal disease and requires chronic dialysis
-
There is clinical support for non-septic shock
-
Subject has had chest compressions as part of CPR
-
Subject has had an acute myocardial infarction (AMI)
-
Subject has uncontrolled hemorrhage
-
Major trauma within 36 hours of screening
-
Subject has severe granulocytopenia
-
HIV infection with a last known or suspected CD4 count of <50/mm3
-
Subject has sustained extensive third-degree burns
-
Body weight < 35 kg (77 pounds)
-
Known hypersensitivity to polymyxin B
-
Subject has known sensitivity or allergy to heparin
-
Subject has screening MOD score of ≤9
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Tucson | Arizona | United States | ||
| 3 | Little Rock | Arkansas | United States | ||
| 4 | Loma Linda | California | United States | ||
| 5 | San Diego | California | United States | ||
| 6 | Stanford | California | United States | ||
| 7 | Colorado Springs | Colorado | United States | ||
| 8 | Newark | Delaware | United States | ||
| 9 | Washington | District of Columbia | United States | ||
| 10 | Augusta | Georgia | United States | ||
| 11 | Idaho Falls | Idaho | United States | ||
| 12 | Oak Park | Illinois | United States | ||
| 13 | Peoria | Illinois | United States | ||
| 14 | Iowa City | Iowa | United States | ||
| 15 | Hazard | Kentucky | United States | ||
| 16 | Baltimore | Maryland | United States | ||
| 17 | Springfield | Massachusetts | United States | ||
| 18 | Ann Arbor | Michigan | United States | ||
| 19 | Detroit | Michigan | United States | ||
| 20 | Rochester | Minnesota | United States | ||
| 21 | Jackson | Mississippi | United States | ||
| 22 | Saint Louis | Missouri | United States | ||
| 23 | Omaha | Nebraska | United States | ||
| 24 | Camden | New Jersey | United States | ||
| 25 | New York | New York | United States | ||
| 26 | Greenville | North Carolina | United States | ||
| 27 | Columbus | Ohio | United States | ||
| 28 | Philadelphia | Pennsylvania | United States | ||
| 29 | Pittsburgh | Pennsylvania | United States | ||
| 30 | Chattanooga | Tennessee | United States | ||
| 31 | Houston | Texas | United States | ||
| 32 | San Antonio | Texas | United States | ||
| 33 | Richmond | Virginia | United States | ||
| 34 | Calgary | Alberta | Canada | ||
| 35 | Edmonton | Alberta | Canada | ||
| 36 | Victoria | British Columbia | Canada | ||
| 37 | Oshawa | Ontario | Canada | ||
| 38 | Ottawa | Ontario | Canada | ||
| 39 | Toronto | Ontario | Canada | ||
| 40 | Quebec City | Quebec | Canada |
Sponsors and Collaborators
- Spectral Diagnostics (US) Inc.
Investigators
- Principal Investigator: Phillip Dellinger, Dr., Cooper Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier:
NCT01046669
Other Study ID Numbers:
- SDI-PMX-NA001
First Posted:
Jan 12, 2010
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019
Study Results
Participant Flow
| Recruitment Details | 450 subjects randomized out of 921 clinically eligible subjects in 55 ICUs. First patient screened in Jun 2010, last patient screened in Jun 2016. |
|---|---|
| Pre-assignment Detail | The following screened subjects were not randomized: Subject's EAA <0.06 EA units Subject met an exclusion criteria prior to randomization Informed consent for the treatment phase of the study was not signed or consent withdrawn prior to randomization. Subjects who were randomized but not treated (RNT) were not part of safety analysis. |
| Arm/Group Title | Sham | Treatment |
|---|---|---|
| Arm/Group Description | Standard medical care for septic shock | Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock. |
| Period Title: Overall Study | ||
| STARTED | 226 | 224 |
| COMPLETED | 226 | 223 |
| NOT COMPLETED | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Sham | Treatment | Total |
|---|---|---|---|
| Arm/Group Description | Standard medical care for septic shock | Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock | Total of all reporting groups |
| Overall Participants | 226 | 224 | 450 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.8
(14.7)
|
60.9
(15.1)
|
59.8
(14.9)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
93
41.2%
|
84
37.5%
|
177
39.3%
|
| Male |
133
58.8%
|
140
62.5%
|
273
60.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
187
82.7%
|
183
81.7%
|
370
82.2%
|
| Black |
13
5.8%
|
22
9.8%
|
35
7.8%
|
| Hispanic |
12
5.3%
|
10
4.5%
|
22
4.9%
|
| Asian |
9
4%
|
3
1.3%
|
12
2.7%
|
| Other |
5
2.2%
|
6
2.7%
|
11
2.4%
|
| Region of Enrollment (participants) [Number] | |||
| Canada |
57
25.2%
|
53
23.7%
|
110
24.4%
|
| United States |
169
74.8%
|
171
76.3%
|
340
75.6%
|
Outcome Measures
| Title | Mortality |
|---|---|
| Description | Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone |
| Time Frame | 28 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| All subjects randomized |
| Arm/Group Title | Sham | Treatment |
|---|---|---|
| Arm/Group Description | Standard medical care for septic shock | Two (2) PMX cartridges administered approximately 24 hours apart plus standard medical care for septic shock |
| Measure Participants | 226 | 224 |
| Count of Participants [Participants] |
78
34.5%
|
84
37.5%
|
Adverse Events
| Time Frame | Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220. | |||
| Arm/Group Title | Sham | Treatment | ||
| Arm/Group Description | Standard medical care for septic shock | Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock. | ||
All Cause Mortality |
||||
| Sham | Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 78/226 (34.5%) | 84/224 (37.5%) | ||
Serious Adverse Events |
||||
| Sham | Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 126/220 (57.3%) | 140/212 (66%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/220 (0.9%) | 2 | 2/212 (0.9%) | 2 |
| Coagulopathy | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Disseminated intravascular coagulation | 2/220 (0.9%) | 2 | 0/212 (0%) | 0 |
| Heparin-induced thrombocytopenia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Leukocytosis | 2/220 (0.9%) | 2 | 0/212 (0%) | 0 |
| Pancytopenia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Thrombocytopenia | 4/220 (1.8%) | 4 | 6/212 (2.8%) | 6 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 2/220 (0.9%) | 2 | 1/212 (0.5%) | 1 |
| Atrial fibrillation | 0/220 (0%) | 0 | 3/212 (1.4%) | 3 |
| Bradycardia | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 3 |
| Cardiac arrest | 12/220 (5.5%) | 14 | 6/212 (2.8%) | 6 |
| Cardiac failure | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Cardiac failure congestive | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Cardio-respiratory arrest | 8/220 (3.6%) | 8 | 2/212 (0.9%) | 2 |
| Cardiogenic shock | 1/220 (0.5%) | 2 | 0/212 (0%) | 0 |
| Cor pulmonale chronic | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Myocardial infarction | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Pericardial effusion | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Pulseless electrical activity | 3/220 (1.4%) | 3 | 1/212 (0.5%) | 1 |
| Sinus bradycardia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Supraventricular tachycardia | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 2 |
| Torsade de pointes | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Endocrine disorders | ||||
| Adrenal harmorrhage | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Eye disorders | ||||
| Retinal detachment | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal compartment syndrome | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Abdominal pain | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 3 |
| Duodenal ulcer haemorrhage | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Enterocutaneous fistula | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Gastrointestinal disorder | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/220 (0.5%) | 1 | 5/212 (2.4%) | 5 |
| Haematochezia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Intestinal perforation | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Obstructive gastric | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Oesophagal perforation | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Oesophagal varices haemorrhage | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Pancreatitis | 2/220 (0.9%) | 2 | 1/212 (0.5%) | 1 |
| Pancreatitis necrotising | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Small intestinal obstruction | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Vomiting | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| General disorders | ||||
| Cardiac Death | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Chest pain | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Death | 1/220 (0.5%) | 1 | 6/212 (2.8%) | 6 |
| Device leakage | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Device malfunction | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Disease progression | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Multi-organ failure | 12/220 (5.5%) | 12 | 14/212 (6.6%) | 14 |
| Terminal state | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Thrombosis in device | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Chronic hepatic failure | 2/220 (0.9%) | 2 | 0/212 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Acute hepatic failure | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 2 |
| Cholangitis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Cholecystitis acute | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Cholecystitis chronic | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Cirrhosis alcoholic | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Hepatic failure | 2/220 (0.9%) | 2 | 4/212 (1.9%) | 4 |
| Hepatic infarction | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Hepatorenal syndrome | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Liver injury | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Portal vein thrombosis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Biliary sepsis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Infections and infestations | ||||
| Abdominal sepsis | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Abscess | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Abscess neck | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Appendicitis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Bacterial sepsis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Cellulitis | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 2 |
| Clostridium difficile colitis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Diverticulitis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Empyema | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Enterococcal infection | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Gangrene | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Necrotising fasciitis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Orchitis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Pneumonia | 3/220 (1.4%) | 3 | 2/212 (0.9%) | 2 |
| Postoperative wound infection | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Pulmonary sepsis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Sepsis | 20/220 (9.1%) | 23 | 23/212 (10.8%) | 26 |
| Septic shock | 16/220 (7.3%) | 17 | 13/212 (6.1%) | 13 |
| Splenic abscess | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Staphylococcal sepsis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Uninary tract infection | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Wound sepsis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Anaphylactic transfusion reaction | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Brain herniation | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Diaphragmatic injury | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Gastrointestinal anastomotic leak | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Gastrointestinal stoma complication | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 2 |
| Injury | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Splenic injury | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Toxicity to various agents | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Wound evisceration | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Investigations | ||||
| Blood lactic acid increased | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 2 |
| Diabetic ketoacidosis | 0/220 (0%) | 0 | 2/212 (0.9%) | 3 |
| Electrolyte imbalance | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Failure to thrive | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Fluid overload | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Hypercalcaemia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Hyponatraemia | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Metabolic acidosis | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Chondrocalcinosis pyrophosphate | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Crystal arthropathy | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Muscular weakness | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Scleroderma | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Soft tissue necrosis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Adrenal carcinoma | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Benign neoplasm | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Chloroma | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Metastatic neoplasm | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Metastatic squamous cell carcinoma | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Multiple myeloma | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Small cell lung cancer stage unspecified | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Nervous system disorders | ||||
| Brain injury | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Brain oedema | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Brain stem stroke | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Cerebral infarction | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 3 |
| Cerebrovascular accident | 2/220 (0.9%) | 2 | 1/212 (0.5%) | 1 |
| Depressed level of consciousness | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Embolic stroke | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Encephalopathy | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Haemorrhagic stroke | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Hepatic encephalopathy | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Hydrocephalus | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Ischaemic stroke | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Presyncope | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Subarachnoid haemorrhage | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Psychiatric disorders | ||||
| Delirium | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Depression | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Eating disorder | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Mental status change | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Renal and urinary disorders | ||||
| Faecaluria | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Nephrolithiasis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Renal failure | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Renal failure acute | 6/220 (2.7%) | 6 | 3/212 (1.4%) | 3 |
| Renal failure chronic | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Reproductive system and breast disorders | ||||
| Aspiration | 3/220 (1.4%) | 4 | 1/212 (0.5%) | 1 |
| Epitaxis | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory distress syndrome | 0/220 (0%) | 0 | 2/212 (0.9%) | 3 |
| Acute respiratory failure | 2/220 (0.9%) | 2 | 1/212 (0.5%) | 1 |
| Atelectasis | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Dyspnoea | 1/220 (0.5%) | 3 | 0/212 (0%) | 0 |
| Haemoptysis | 0/220 (0%) | 0 | 2/212 (0.9%) | 3 |
| Haemothorax | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Hypoxia | 1/220 (0.5%) | 1 | 2/212 (0.9%) | 2 |
| Pleural effusion | 0/220 (0%) | 0 | 4/212 (1.9%) | 4 |
| Pneumonia aspiration | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Pneumothorax | 2/220 (0.9%) | 2 | 1/212 (0.5%) | 1 |
| Pulmonary embolism | 1/220 (0.5%) | 1 | 1/212 (0.5%) | 1 |
| Pulmonary oedema | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Respiratory arrest | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Respiratory distress | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Respiratory failure | 10/220 (4.5%) | 11 | 8/212 (3.8%) | 10 |
| Tachypnoea | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Decubitus ulcer | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Purpura fulminans | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Steven-Johnson syndrome | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Vascular disorders | ||||
| Arteriosclerosis | 0/220 (0%) | 0 | 1/212 (0.5%) | 4 |
| Bleeding varicose vein | 0/220 (0%) | 1/212 (0.5%) | 1 | |
| Deep vein thrombosis | 2/220 (0.9%) | 2 | 2/212 (0.9%) | 2 |
| Embolism | 0/220 (0%) | 0 | 2/212 (0.9%) | 2 |
| Embolism venous | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Haematoma | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Haemorrhage | 1/220 (0.5%) | 2 | 1/212 (0.5%) | 1 |
| Hypotension | 2/220 (0.9%) | 2 | 2/212 (0.9%) | 2 |
| Infarction | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Ischaemia | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Peripheral ischaemia | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
| Shock haemorrhagic | 0/220 (0%) | 0 | 1/212 (0.5%) | 1 |
| Vascular insufficiency | 1/220 (0.5%) | 1 | 0/212 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Sham | Treatment | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 60/220 (27.3%) | 56/212 (26.4%) | ||
| Cardiac disorders | ||||
| Cardiac arrest | 12/220 (5.5%) | 14 | 6/212 (2.8%) | 6 |
| General disorders | ||||
| Multi-organ failure | 12/220 (5.5%) | 12 | 14/212 (6.6%) | 14 |
| Infections and infestations | ||||
| Sepsis | 20/220 (9.1%) | 23 | 23/212 (10.8%) | 26 |
| Septic shock | 16/220 (7.3%) | 17 | 13/212 (6.1%) | 13 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor will be given a copy of the disclosure for review at least 60 days prior to the date of submission for publication or public disclosure. Sponsor may request to delete confidential information, other than study data. PI agrees to discuss with sponsor any of sponsor's suggestions with respect to the presentation of study data and the timing of the disclosure.
Results Point of Contact
| Name/Title | Debra Foster, VP Clinical Development |
|---|---|
| Organization | Spectral Diagnostics Inc. |
| Phone | 4166263233 ext 2001 |
| dfoster@spectraldx.com |
Responsible Party:
Spectral Diagnostics (US) Inc.
ClinicalTrials.gov Identifier:
NCT01046669
Other Study ID Numbers:
- SDI-PMX-NA001
First Posted:
Jan 12, 2010
Last Update Posted:
Feb 26, 2019
Last Verified:
Feb 1, 2019