Trial Outcomes & Findings for Vitamin D in Ventilated ICU Patients (NCT NCT01372995)

NCT ID: NCT01372995

Last Updated: 2017-01-09

Results Overview

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-01-09

Participant Flow

Study participants were recruited from critical care units at three hospitals in Atlanta, Georgia. 658 patients were assessed for eligibility, of these 562 did not meet inclusion and exclusion criteria. 65 eligible patients declined to participate while 31 gave informed consent and were randomized to one of the three study arms.

Participant milestones

Measure	Placebo Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Study STARTED	10	10	11
Overall Study COMPLETED	10	9	10
Overall Study NOT COMPLETED	0	1	1

Reasons for withdrawal

Measure	Placebo Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Overall Study Spouse withdrew participant from study	0	1	0
Overall Study Physician Decision	0	0	1

Baseline Characteristics

Vitamin D in Ventilated ICU Patients

Baseline characteristics by cohort

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Gender Female	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Gender Male	6 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized African American	4 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	14 participants n=4 Participants
Race/Ethnicity, Customized Caucasian	5 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaskan	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	11 participants n=5 Participants	30 participants n=4 Participants
Vitamin D at baseline Deficient (<20 ng/mL)	5 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	13 participants n=4 Participants
Vitamin D at baseline Insufficient (20-30 ng/mL)	3 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	12 participants n=4 Participants
Vitamin D at baseline Sufficient (>30 ng/mL)	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants
Coronary Artery Disease Coronary Artery Disease Present	1 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	10 participants n=4 Participants
Coronary Artery Disease No Coronary Artery Disease	9 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	20 participants n=4 Participants
Congestive Heart Failure Congestive Heart Failure Present	1 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	8 participants n=4 Participants
Congestive Heart Failure No Congestive Heart Failure	9 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	22 participants n=4 Participants
Diabetes Diabetes Present	4 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	7 participants n=4 Participants
Diabetes No Diabetes	6 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	23 participants n=4 Participants
Chronic Obstructive Pulmonary Disease (COPD) COPD Present	2 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants
Chronic Obstructive Pulmonary Disease (COPD) No COPD	8 participants n=5 Participants	8 participants n=7 Participants	7 participants n=5 Participants	23 participants n=4 Participants
Asthma Asthma Present	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Asthma No Asthma	9 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants	28 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline	2 participants	2 participants	1 participants

PRIMARY outcome

Timeframe: Day 7

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.

Outcome measures

Measure	Placebo n=9 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=6 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7	2 participants	4 participants	9 participants

PRIMARY outcome

Timeframe: Day 14

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=6 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=5 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14	2 participants	5 participants	5 participants

PRIMARY outcome

Timeframe: Day 21

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.

Outcome measures

Measure	Placebo n=4 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=4 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=2 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21	1 participants	3 participants	2 participants

PRIMARY outcome

Timeframe: Day 28

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.

Outcome measures

Measure	Placebo n=3 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=2 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=1 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28	0 participants	2 participants	1 participants

PRIMARY outcome

Timeframe: Day 84

Population: Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.

The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.

Outcome measures

Measure	Placebo n=1 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=2 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=1 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 14

Population: For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.

Plasma LL-37 was measured at Baseline, Day 7 and Day 14.

Outcome measures

Measure	Placebo n=8 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=6 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=5 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Change in Plasma LL-37 Levels Day 14 Compared to Baseline	1.1 ng/mL Interval -24.6 to 10.8	-12.3 ng/mL Interval -36.1 to 8.1	-6.0 ng/mL Interval -27.3 to 2.0
Change in Plasma LL-37 Levels Day 7 Compared to Baseline	-3.8 ng/mL Interval -18.9 to 26.9	6.0 ng/mL Interval -13.4 to 39.2	-13.5 ng/mL Interval -48.4 to 37.4

SECONDARY outcome

Timeframe: 12 weeks

The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Duration of Time on Ventilator	20 days Standard Deviation 15	12 days Standard Deviation 10	14 days Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks

The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Duration of Time in Intensive Care Unit (ICU)	23 days Standard Deviation 14	17 days Standard Deviation 14	15 days Standard Deviation 10

SECONDARY outcome

Timeframe: 12 weeks

The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Duration of Time in Hospital	36 days Standard Deviation 19	25 days Standard Deviation 14	18 days Standard Deviation 11

SECONDARY outcome

Timeframe: Baseline, Day 7

Population: SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..

Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=7 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Change in Sequential Organ Failure Assessment (SOFA) Score	-2 units on a scale Standard Deviation 3	-3 units on a scale Standard Deviation 3	-2 units on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: 12 weeks

The number of study participants who had a hospital acquired infection.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=11 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Hospital Acquired Infections	3 participants	3 participants	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.

The number of study participants who died while in the hospital was collected.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=10 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Number of Hospital Mortality Cases	1 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Day 84

Population: The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.

The number of participants who died prior to the end of the study (Day 84) was collected.

Outcome measures

Measure	Placebo n=10 Participants Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 Participants Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally	500,000 IU of Vitamin D3 n=10 Participants Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
Day 84 Mortality	2 participants	1 participants	4 participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

250,000 IU of Vitamin D3

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

500,000 IU of Vitamin D3

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=10 participants at risk Participants randomized to receive an inactive substance administered enterally for 5 days	250,000 IU of Vitamin D3 n=9 participants at risk Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.	500,000 IU of Vitamin D3 n=11 participants at risk Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
General disorders Re-hospitalization	10.0% 1/10 • Number of events 1 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	11.1% 1/9 • Number of events 1 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	0.00% 0/11 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.
General disorders Death	0.00% 0/10 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	0.00% 0/9 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	9.1% 1/11 • Number of events 1 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.
Cardiac disorders Cardiopulmonary arrest	0.00% 0/10 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	0.00% 0/9 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.	9.1% 1/11 • Number of events 1 • Data regarding serious adverse events and non-serious adverse events were collected from the start of treatment until 30 days after study drug discontinuation (35 days in total). Ongoing events were monitored until resolution. As critically ill study patients are known to have a high morbidity and mortality rate, no adverse events specifically due to the study drug were expected. The clinical course of every participant was monitored to record any unexpected adverse events and all serious adverse events (SAEs). SAEs were defined as death, rehospitalization or reoperation within 30 days, cardiopulmonary arrest, pulmonary aspiration during feeding tube administration, new cancer diagnosis, and congenital anomalies.

Other adverse events

Adverse event data not reported

Additional Information

Jenny Han, MD

Emory University

Phone: 404-616-0821

Email: jehan2@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place