Stress Hyperglycemia
Conditions
Keywords
Coronary Artery Bypass Surgery (CABG), Post Operative, Obesity
Brief summary
This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.
Detailed description
Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-diabetes mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia. The main goals of this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery. To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress, obese patients without diabetes mellitus undergoing CABG surgery will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.
Interventions
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
OTHERSaline Injection
Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery
Sponsors
National Institute of General Medical Sciences (NIGMS)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective placebo controlled randomized study
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between the ages of 40 and 80 years * Body mass index (BMI) ≥25 * Undergoing elective CABG surgery * No previous history of diabetes or hyperglycemia
Exclusion criteria
* Hyperglycemia (BG\>125 mg/dl or HbA1c \> 6.5%) or previous treatment with antidiabetic agents * Impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure * Gastrointestinal obstruction expected to require gastrointestinal suction * Patients with clinically relevant pancreatic or gallbladder disease * Treatment with oral or injectable corticosteroid * Mental condition rendering the subject unable to understand the possible consequences of the study * Pregnancy or breastfeeding at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period | During the hospital stay (up to 12 days postoperatively) | Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Needing CII Treatment in the ICU | During the ICU stay (up to 7 days postoperatively) | Patients with two consecutive BG \>180 mg/dl, or average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants needing CII while in the ICU postoperatively was compared between patients randomized to dulaglutide or placebo study arms. |
| Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII | During the hospital stay (up to 12 days postoperatively) | Patients with two consecutive BG \>180 mg/dl, or an average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants in need of rescue therapy with subcutaneous insulin postoperatively, after CII was discontinued, was compared between study arms. |
| Mean Blood Glucose Levels During the Hospital Stay | During the hospital stay (up to 12 days postoperatively) | To measure glucose control, the mean blood glucose levels in mg/dL during the non-ICU hospital stay postoperatively were measured. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. |
| Mean Units Per Hour of Insulin While in the ICU | During the ICU stay (up to 7 days postoperatively) | The mean insulin dose during the time that participants were in the ICU is assessed as insulin infusion units per hour. |
| Mean Insulin Dose Per Day While in the ICU | During the ICU stay (up to 7 days postoperatively) | The mean insulin dose during the time that participants were in the ICU is assessed as insulin units per day. |
| Duration of Continuous Insulin Infusion (CII) | During the hospital stay (up to 12 days postoperatively) | The duration of continuous insulin infusion (CII) is assessed in hours. |
| Days of Subcutaneous (SC) Insulin After Discontinuation of CII | During the hospital stay (up to 12 days postoperatively) | Subcutaneous (SC) insulin use after continuous insulin infusion (CII) is discontinued is assessed as the number of days that SC insulin was required. |
| Amount of SC Insulin Administered | During the hospital stay (up to 12 days postoperatively) | The amount of subcutaneous (SC) insulin administered during the ICU and non-ICU hospital stay, among participants requiring SC insulin after discontinuing CII. |
| Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively | During the ICU stay (up to 7 days postoperatively) | To measure glucose control, the mean blood glucose levels in mg/dL were measured during the postoperative Intensive Care Unit (ICU) stay. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. |
| Number of Participants Experiencing Hypoglycemic Events | During the hospital stay (up to 12 days postoperatively) | Hypoglycemic events are defined as BG \<70, \< 54, and \<40 mg/dl occurring during ICU and non-ICU hospital stay. |
| Number of Participants Experiencing Mortality and Complications | During the hospital stay (up to 12 days postoperatively) | The number of participants experiencing a composite of mortality and complications. Complications include sternal wound infection, bacteremia, pneumonia, acute kidney injury, and acute myocardial infarction. |
| Number of Participants Experiencing Gastrointestinal Adverse Events | During the hospital stay (up to 12 days postoperatively) | The number participants who experienced gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis. |
| ICU Length of Stay | During the ICU stay (up to 7 days postoperatively) | ICU length of stay is assessed as the mean number of days participants in each study arm spent in the ICU. |
| Hospital Length of Stay | During the hospital stay (up to 12 days postoperatively) | Hospital length of stay is assessed as the mean number of days participants in each study arm spent in the hospital. |
| Number of ICU Readmissions | During the hospital stay (up to 12 days postoperatively) | The number of readmissions to the ICU. |
| Number of Cerebrovascular Events | During the hospital stay (up to 12 days postoperatively) | The number of cerebrovascular events. |
| Participant Mortality | During the hospital stay (up to 12 days postoperatively) | The number of participant deaths while in the ICU and hospital. |
| Number of Participants Experiencing Hyperglycemic Events | During the hospital stay (up to 12 days postoperatively) | Hyperglycemic events are defined as BG \> 200 mg/dl, during ICU and non-ICU hospital stay. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Grady Memorial Hospital, Emory University Hospital Midtown, and Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began March 8, 2019 and the final study assessment occurred on May 2, 2023.
Participants by arm
| Arm | Count |
|---|---|
| Dulaglutide Participants without a history of DM who were randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery. | 14 |
| Placebo Participants without a history of DM who were randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgery was cancelled | 2 | 1 |
Baseline characteristics
| Characteristic | Dulaglutide | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Continuous | 58.00 years STANDARD_DEVIATION 11.62 | 61.50 years STANDARD_DEVIATION 10.86 | 59.40 years STANDARD_DEVIATION 10.87 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 12 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 12 Participants | 23 Participants |
| Region of Enrollment United States | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 4 / 12 | 2 / 13 |
| serious Total, serious adverse events | 1 / 12 | 0 / 13 |
Outcome results
Primary
Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period
Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels \>140 milligrams per deciliter (mg/dL). Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period | 11 Participants |
| Placebo | Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period | 13 Participants |
Secondary
Amount of SC Insulin Administered
The amount of subcutaneous (SC) insulin administered during the ICU and non-ICU hospital stay, among participants requiring SC insulin after discontinuing CII.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU and subsequent SC after discontinuation of CII.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Amount of SC Insulin Administered | 8.25 units of insulin | Standard Deviation 14.28 |
| Placebo | Amount of SC Insulin Administered | 10.92 units of insulin | Standard Deviation 10.44 |
Secondary
Days of Subcutaneous (SC) Insulin After Discontinuation of CII
Subcutaneous (SC) insulin use after continuous insulin infusion (CII) is discontinued is assessed as the number of days that SC insulin was required.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU and subsequent SC after discontinuation of CII.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Days of Subcutaneous (SC) Insulin After Discontinuation of CII | 2.00 days | Standard Deviation 1.09 |
| Placebo | Days of Subcutaneous (SC) Insulin After Discontinuation of CII | 3.50 days | Standard Deviation 2.08 |
Secondary
Duration of Continuous Insulin Infusion (CII)
The duration of continuous insulin infusion (CII) is assessed in hours.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Duration of Continuous Insulin Infusion (CII) | 18.90 hours | Standard Deviation 5.6 |
| Placebo | Duration of Continuous Insulin Infusion (CII) | 16.69 hours | Standard Deviation 6.31 |
Secondary
Hospital Length of Stay
Hospital length of stay is assessed as the mean number of days participants in each study arm spent in the hospital.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Hospital Length of Stay | 7.25 days | Standard Deviation 2.92 |
| Placebo | Hospital Length of Stay | 8.92 days | Standard Deviation 3.72 |
Secondary
ICU Length of Stay
ICU length of stay is assessed as the mean number of days participants in each study arm spent in the ICU.
Time frame: During the ICU stay (up to 7 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | ICU Length of Stay | 2.19 days | Standard Deviation 1.45 |
| Placebo | ICU Length of Stay | 2.76 days | Standard Deviation 1.59 |
Secondary
Mean Blood Glucose Levels During the Hospital Stay
To measure glucose control, the mean blood glucose levels in mg/dL during the non-ICU hospital stay postoperatively were measured. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Mean Blood Glucose Levels During the Hospital Stay | 119.69 mg/dL | Standard Deviation 23.5 |
| Placebo | Mean Blood Glucose Levels During the Hospital Stay | 117.69 mg/dL | Standard Deviation 20.59 |
Secondary
Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively
To measure glucose control, the mean blood glucose levels in mg/dL were measured during the postoperative Intensive Care Unit (ICU) stay. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
Time frame: During the ICU stay (up to 7 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively | 134.11 mg/dL | Standard Deviation 14 |
| Placebo | Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively | 129.79 mg/dL | Standard Deviation 11.42 |
Secondary
Mean Insulin Dose Per Day While in the ICU
The mean insulin dose during the time that participants were in the ICU is assessed as insulin units per day.
Time frame: During the ICU stay (up to 7 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Mean Insulin Dose Per Day While in the ICU | 61.15 insulin units/day | Standard Deviation 66.84 |
| Placebo | Mean Insulin Dose Per Day While in the ICU | 33.01 insulin units/day | Standard Deviation 20.19 |
Secondary
Mean Units Per Hour of Insulin While in the ICU
The mean insulin dose during the time that participants were in the ICU is assessed as insulin infusion units per hour.
Time frame: During the ICU stay (up to 7 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulaglutide | Mean Units Per Hour of Insulin While in the ICU | 2.89 insulin units/hour | Standard Deviation 2.6 |
| Placebo | Mean Units Per Hour of Insulin While in the ICU | 2.01 insulin units/hour | Standard Deviation 0.98 |
Secondary
Number of Cerebrovascular Events
The number of cerebrovascular events.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dulaglutide | Number of Cerebrovascular Events | 0 cerebrovascular events |
| Placebo | Number of Cerebrovascular Events | 0 cerebrovascular events |
Secondary
Number of ICU Readmissions
The number of readmissions to the ICU.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dulaglutide | Number of ICU Readmissions | 0 ICU readmissions |
| Placebo | Number of ICU Readmissions | 0 ICU readmissions |
Secondary
Number of Participants Experiencing Gastrointestinal Adverse Events
The number participants who experienced gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants Experiencing Gastrointestinal Adverse Events | 3 Participants |
| Placebo | Number of Participants Experiencing Gastrointestinal Adverse Events | 1 Participants |
Secondary
Number of Participants Experiencing Hyperglycemic Events
Hyperglycemic events are defined as BG \> 200 mg/dl, during ICU and non-ICU hospital stay.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants Experiencing Hyperglycemic Events | 1 Participants |
| Placebo | Number of Participants Experiencing Hyperglycemic Events | 2 Participants |
Secondary
Number of Participants Experiencing Hypoglycemic Events
Hypoglycemic events are defined as BG \<70, \< 54, and \<40 mg/dl occurring during ICU and non-ICU hospital stay.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dulaglutide | Number of Participants Experiencing Hypoglycemic Events | BG <70 mg/dL | 0 Participants |
| Dulaglutide | Number of Participants Experiencing Hypoglycemic Events | BG <54 mg/dL | 0 Participants |
| Dulaglutide | Number of Participants Experiencing Hypoglycemic Events | BG <40 mg/dL | 0 Participants |
| Placebo | Number of Participants Experiencing Hypoglycemic Events | BG <70 mg/dL | 0 Participants |
| Placebo | Number of Participants Experiencing Hypoglycemic Events | BG <54 mg/dL | 0 Participants |
| Placebo | Number of Participants Experiencing Hypoglycemic Events | BG <40 mg/dL | 0 Participants |
Secondary
Number of Participants Experiencing Mortality and Complications
The number of participants experiencing a composite of mortality and complications. Complications include sternal wound infection, bacteremia, pneumonia, acute kidney injury, and acute myocardial infarction.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants Experiencing Mortality and Complications | 2 Participants |
| Placebo | Number of Participants Experiencing Mortality and Complications | 1 Participants |
Secondary
Number of Participants Needing CII Treatment in the ICU
Patients with two consecutive BG \>180 mg/dl, or average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants needing CII while in the ICU postoperatively was compared between patients randomized to dulaglutide or placebo study arms.
Time frame: During the ICU stay (up to 7 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants Needing CII Treatment in the ICU | 11 Participants |
| Placebo | Number of Participants Needing CII Treatment in the ICU | 12 Participants |
Secondary
Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII
Patients with two consecutive BG \>180 mg/dl, or an average daily BG \>180 mg/dl were started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily. Information on BG measurements was collected both at bedside by glucose meter and by hospital laboratory. BG was measured every 1-2 hours during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards. The number of participants in need of rescue therapy with subcutaneous insulin postoperatively, after CII was discontinued, was compared between study arms.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who required CII while in the ICU.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulaglutide | Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII | 6 Participants |
| Placebo | Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII | 4 Participants |
Secondary
Participant Mortality
The number of participant deaths while in the ICU and hospital.
Time frame: During the hospital stay (up to 12 days postoperatively)
Population: This analysis includes participants who completed the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dulaglutide | Participant Mortality | ICU deaths | 0 Participants |
| Dulaglutide | Participant Mortality | Non-ICU hospital deaths | 0 Participants |
| Placebo | Participant Mortality | ICU deaths | 0 Participants |
| Placebo | Participant Mortality | Non-ICU hospital deaths | 0 Participants |