Trial Outcomes & Findings for Core Warming in COVID-19 Patients Undergoing Mechanical Ventilation (NCT NCT04494867)
NCT ID: NCT04494867
Last Updated: 2023-03-09
Results Overview
Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
0, 24, 48, and 72 hours after initiation of core warming
Results posted on
2023-03-09
Participant Flow
Participant milestones
| Measure |
Core Warming
Patients assigned to receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
Patients assigned to receive standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Core Warming
n=9 Participants
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 Participants
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=9 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=19 Participants
|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 15.1 • n=9 Participants
|
59.4 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
60.5 years
STANDARD_DEVIATION 12.5 • n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
10 participants
n=10 Participants
|
19 participants
n=19 Participants
|
|
Time to Enrollment
|
9.4 days
STANDARD_DEVIATION 13.1 • n=9 Participants
|
9.1 days
STANDARD_DEVIATION 11.8 • n=10 Participants
|
9.3 days
STANDARD_DEVIATION 12.1 • n=19 Participants
|
|
Height
|
1.623 meters
STANDARD_DEVIATION 0.104 • n=9 Participants
|
1.687 meters
STANDARD_DEVIATION 0.098 • n=10 Participants
|
1.66 meters
STANDARD_DEVIATION 0.10 • n=19 Participants
|
|
Weight
|
94.8 kilograms
STANDARD_DEVIATION 23.5 • n=9 Participants
|
95.2 kilograms
STANDARD_DEVIATION 14.2 • n=10 Participants
|
95.1 kilograms
STANDARD_DEVIATION 18.6 • n=19 Participants
|
|
Body Mass Index
|
35.8 kg/m^2
STANDARD_DEVIATION 7.8 • n=9 Participants
|
33.4 kg/m^2
STANDARD_DEVIATION 3.4 • n=10 Participants
|
34.5 kg/m^2
STANDARD_DEVIATION 5.9 • n=19 Participants
|
|
Tobacco Usage
|
1 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=19 Participants
|
|
Ethanol Usage
|
1 Participants
n=9 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=19 Participants
|
|
Pre-Existing Cardiovascular Condition
|
6 Participants
n=9 Participants
|
8 Participants
n=10 Participants
|
14 Participants
n=19 Participants
|
|
Pre-Existing Respiratory Condition at Baseline
|
6 Participants
n=9 Participants
|
7 Participants
n=10 Participants
|
13 Participants
n=19 Participants
|
|
Pre-Existing Hepatic Condition
|
2 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=19 Participants
|
|
Pre-Existing Gastrointestinal Condition
|
1 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=19 Participants
|
|
Pre-Existing Genitourinary Condition at Baseline
|
3 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=19 Participants
|
|
Pre-Existing Endocrine Condition
|
8 Participants
n=9 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=19 Participants
|
|
Pre-Existing Hematologic Condition
|
5 Participants
n=9 Participants
|
6 Participants
n=10 Participants
|
11 Participants
n=19 Participants
|
|
Pre-Existing Musculoskeletal Condition
|
6 Participants
n=9 Participants
|
8 Participants
n=10 Participants
|
14 Participants
n=19 Participants
|
|
Pre-Existing Neoplastic Condition
|
0 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=19 Participants
|
|
Pre-Existing Neurologic Condition
|
2 Participants
n=9 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=19 Participants
|
|
Pre-Existing Psychiatric Condition
|
2 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=19 Participants
|
|
Pre-Existing Immunologic Condition
|
3 Participants
n=9 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=19 Participants
|
|
Pre-Existing Dermatologic Condition
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Pre-Existing HEENT Condition
|
1 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=19 Participants
|
|
Other Pre-Existing Condition
|
3 Participants
n=9 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=19 Participants
|
|
Allergies
|
0 Participants
n=9 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=19 Participants
|
|
Baseline Cycle Threshold
|
31.7 Cycles
STANDARD_DEVIATION 1.6 • n=9 Participants
|
27.1 Cycles
STANDARD_DEVIATION 1.45 • n=10 Participants
|
29.1 Cycles
STANDARD_DEVIATION 4.8 • n=19 Participants
|
PRIMARY outcome
Timeframe: 0, 24, 48, and 72 hours after initiation of core warmingDetermine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Outcome measures
| Measure |
Core Warming
n=9 Participants
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 Participants
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
PaO2/FiO2 Ratio
0-hour timepoint
|
119.1435 Ratio
Standard Error 11.57574
|
164.789 Ratio
Standard Error 19.42075
|
|
PaO2/FiO2 Ratio
24-hour timepoint
|
130.0138 Ratio
Standard Error 17.01536
|
154.9758 Ratio
Standard Error 21.10532
|
|
PaO2/FiO2 Ratio
48-hour timepoint
|
158.2389 Ratio
Standard Error 19.43118
|
196.7167 Ratio
Standard Error 30.56792
|
|
PaO2/FiO2 Ratio
72-hour timepoint
|
134.3884 Ratio
Standard Error 13.41839
|
196.9593 Ratio
Standard Error 32.0182
|
SECONDARY outcome
Timeframe: 72 hours after initiation of core warmingDetermine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care.
Outcome measures
| Measure |
Core Warming
n=9 Participants
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 Participants
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
Cycle Threshold at 72-hours
|
31.4 Cycles
Standard Deviation 3.2
|
30.8 Cycles
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Initiation of Core Warming Until Patient Weaned Off Mechanical VentilationMeasure the impact of core warming on duration of mechanical ventilation.
Outcome measures
| Measure |
Core Warming
n=9 Participants
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 Participants
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
Ventilator-Free Days
|
6.8 days
Standard Deviation 10.2
|
11.9 days
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 30 days after initiation of core warmingDetermine impact of core warming on patient mortality.
Outcome measures
| Measure |
Core Warming
n=9 Participants
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 Participants
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
30-Day Mortality
|
2 Participants
|
4 Participants
|
Adverse Events
Core Warming
Serious events: 1 serious events
Other events: 9 other events
Deaths: 2 deaths
Standard of Care
Serious events: 2 serious events
Other events: 9 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Core Warming
n=9 participants at risk
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 participants at risk
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
Infections and infestations
MSSA Bacteremia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
Stenotrophomonas maltophilia pneumonia and bacteremia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
Worsening of bilateral upper/lower extremity weakness
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
Other adverse events
| Measure |
Core Warming
n=9 participants at risk
Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming
Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
|
Standard of Care
n=10 participants at risk
Patients who received standard temperature management and treatment
Standard of Care: Standard temperature management and treatment
|
|---|---|---|
|
Infections and infestations
Fever
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Endocrine disorders
Diabetes mellitus
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
tachycardia
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
20.0%
2/10 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
fungal infection
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
headache
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Immune system disorders
elevated D-dimer
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
20.0%
2/10 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
delirium
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
20.0%
2/10 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
hypertension
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Hepatobiliary disorders
elevated liver function tests
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
20.0%
2/10 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
anemia
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
20.0%
2/10 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
|
Renal and urinary disorders
adrenal insufficiency
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
E. coli pneumonia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
hypotension
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
pseudomonas aeruginosa pneumonia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
tracheobronchitis
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
E. coli bacteremia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
premature atrial contractions
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Hepatobiliary disorders
hepatic steatosis
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
penile skin yeast infection
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Immune system disorders
elevated procalcitonin
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Endocrine disorders
PTH intact
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
septic shock
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Musculoskeletal and connective tissue disorders
supraglottic edema
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Musculoskeletal and connective tissue disorders
dysphagia
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
stammering
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
stool positive for occult blood
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Immune system disorders
toxic vacuoles
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
elevated troponin
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
elevated eosinophils
|
0.00%
0/9 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Immune system disorders
leukocytosis
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
10.0%
1/10 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
bacterial superinfection
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
azotemia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
mild respiratory alkalosis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
heparin-induced thrombocytopenia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Skin and subcutaneous tissue disorders
possible herpes stomatitis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Hepatobiliary disorders
hyperammonia cholestasis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Renal and urinary disorders
acute kidney injury
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
hyperglycemia
|
22.2%
2/9 • Number of events 2 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
toxic metabolic encephalopathy
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
ileus
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
nausea
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
vomiting
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
low phosphorous level
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Vascular disorders
femoral DVT
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
Klebsiella pneumonia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Cardiac disorders
aortic valve stenosis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
head tremor
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
tracheostomy leak
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Skin and subcutaneous tissue disorders
tracheostomy wound infection
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Respiratory, thoracic and mediastinal disorders
tracheobronchomalacia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
elevated PTT
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
mastoiditis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
elevated BUN
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
tinea corpus under pannus
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Vascular disorders
anasarca
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
epistaxis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
acute encephalopathy
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
elevated CA-125 tumor marker
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
elevated carcino-embyonic antigen
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
leukopenia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
sepsis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Renal and urinary disorders
acute tubular necrosis
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Gastrointestinal disorders
duodenal ulcers
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Nervous system disorders
tongue deviation
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Metabolism and nutrition disorders
hypokalemia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Infections and infestations
enterobacter penumonia
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
|
Blood and lymphatic system disorders
elevated RDW
|
11.1%
1/9 • Number of events 1 • Until 30 days post randomization or until hospital discharge
|
0.00%
0/10 • Until 30 days post randomization or until hospital discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place