Trial Outcomes & Findings for Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients (NCT NCT00133978)
NCT ID: NCT00133978
Last Updated: 2021-01-07
Results Overview
28-day mortality/status: at 28 days after randomization;
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1223 participants
Primary outcome timeframe
Day 28
Results posted on
2021-01-07
Participant Flow
This trial was conducted between April 2005 and December 2011 in 40 ICUs in participating countries after local jurisdictional and institutional Research Ethics Board approval.
Written informed consent was obtained from patients or their legal representatives before enrollment.
Participant milestones
| Measure |
Glutamine
Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
|
Antioxidants
Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
|
Glutamine + Antioxidants
Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
|
Placebo
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
303
|
308
|
310
|
302
|
|
Overall Study
COMPLETED
|
301
|
307
|
310
|
300
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
Baseline characteristics by cohort
| Measure |
Glutamine
n=301 Participants
Glutamine supplementation
|
Antioxidants
n=307 Participants
Antioxidant supplementation
|
Glutamine + Antioxidants
n=310 Participants
Glutamine and antioxidant supplementation
|
Placebo
n=300 Participants
Non-isonitrogenic, iso-caloric placebo solution
|
Total
n=1218 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
161 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
621 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
140 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
597 Participants
n=21 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
63.3 years
STANDARD_DEVIATION 14.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
492 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
191 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
726 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
259 participants
n=5 Participants
|
262 participants
n=7 Participants
|
263 participants
n=5 Participants
|
260 participants
n=4 Participants
|
1044 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
31 participants
n=4 Participants
|
131 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Switzerland
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 2828-day mortality/status: at 28 days after randomization;
Outcome measures
| Measure |
Glutamine
n=301 Participants
Glutamine supplementation
|
Antioxidants
n=307 Participants
Antioxidant supplementation
|
Glutamine + Antioxidants
n=310 Participants
Glutamine and antioxidant supplementation
|
Placebo
n=300 Participants
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
28-day Mortality
|
97 participants
|
89 participants
|
101 participants
|
76 participants
|
SECONDARY outcome
Timeframe: Day 28Measure of the duration of participant stay in the ICU
Outcome measures
| Measure |
Glutamine
n=301 Participants
Glutamine supplementation
|
Antioxidants
n=307 Participants
Antioxidant supplementation
|
Glutamine + Antioxidants
n=310 Participants
Glutamine and antioxidant supplementation
|
Placebo
n=300 Participants
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
ICU Length of Stay
|
8.9 days
Interval 5.6 to 16.0
|
8.9 days
Interval 4.8 to 15.6
|
8.9 days
Interval 5.0 to 15.1
|
8.3 days
Interval 4.3 to 16.9
|
SECONDARY outcome
Timeframe: Day 28We have made some modifications the definitions developed by the International Sepsis Forum Consensus Conference (CCM 2005;33:1538-1548) to operationalize the adjudication of infections in this trial. We grade the certainty of the diagnosis of infection using definitions for 'Definite', 'Probable', and 'Possible' for each category of infection. The categories of infection are: Deep surgical wound infection, Incisional (or superficial) surgical wound infection, Skin and soft-tissue infection (non-surgical) (SSTS), Catheter-related blood stream infections (CRI), Primary blood stream infections (BSI), Lower urinary tract infection, Upper urinary tract infection, Intra abdominal infection, Sinusitis, Lower respiratory tract infection (excluding pneumonia), ICU Acquired Pneumonia and Other.
Outcome measures
| Measure |
Glutamine
n=611 Participants
Glutamine supplementation
|
Antioxidants
n=607 Participants
Antioxidant supplementation
|
Glutamine + Antioxidants
n=617 Participants
Glutamine and antioxidant supplementation
|
Placebo
n=601 Participants
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
ICU Acquired Infection
All Infections
|
183 participants
|
166 participants
|
168 participants
|
181 participants
|
|
ICU Acquired Infection
Infections classified as 'definite' or 'probable'
|
118 participants
|
120 participants
|
110 participants
|
128 participants
|
|
ICU Acquired Infection
Microbiological Confirmed
|
92 participants
|
87 participants
|
83 participants
|
96 participants
|
SECONDARY outcome
Timeframe: 6 months (from ICU admission)Measure of the duration of the participant's hospital stay
Outcome measures
| Measure |
Glutamine
n=301 Participants
Glutamine supplementation
|
Antioxidants
n=307 Participants
Antioxidant supplementation
|
Glutamine + Antioxidants
n=310 Participants
Glutamine and antioxidant supplementation
|
Placebo
n=300 Participants
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
17.1 days
Interval 9.0 to 35.1
|
16.0 days
Interval 8.0 to 31.4
|
16.9 days
Interval 8.2 to 37.0
|
16.5 days
Interval 7.2 to 36.2
|
Adverse Events
Glutamine
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Antioxidants
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Glutamine + Antioxidants
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Glutamine
n=301 participants at risk
Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
|
Antioxidants
n=307 participants at risk
Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
|
Glutamine + Antioxidants
n=310 participants at risk
Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
|
Placebo
n=300 participants at risk
Non-isonitrogenic, iso-caloric placebo solution
|
|---|---|---|---|---|
|
Nervous system disorders
Nervous System Disorders
|
1.3%
4/301 • Number of events 4 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.98%
3/307 • Number of events 3 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.65%
2/310 • Number of events 2 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.67%
2/300 • Number of events 2 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorders
|
0.00%
0/301 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.33%
1/307 • Number of events 1 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/310 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/300 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Cardiac disorders
Cardiac Disorders
|
2.3%
7/301 • Number of events 7 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.65%
2/307 • Number of events 2 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
1.6%
5/310 • Number of events 5 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
1.7%
5/300 • Number of events 5 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Gastrointestinal disorders
GI Disease
|
0.66%
2/301 • Number of events 2 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
1.6%
5/307 • Number of events 5 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.97%
3/310 • Number of events 3 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
1.7%
5/300 • Number of events 5 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
0.00%
0/301 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/301 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.32%
1/310 • Number of events 1 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/300 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/301 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/307 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.32%
1/310 • Number of events 1 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/300 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Eye disorders
Eye Disorders
|
0.00%
0/301 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.33%
1/307 • Number of events 1 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/310 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/300 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
|
Surgical and medical procedures
Procedural Complications
|
0.33%
1/301 • Number of events 1 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/307 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.00%
0/310 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
0.67%
2/300 • Number of events 2 • April 2005 and December 2011
We collect data related to these hospitalized, critically ill patients' baseline illness in the CRF (e.g. abnormalities in oxygenation or ventilation, hemodynamic measures, etc). We reported changes in patients' baseline condition, events that are inconsistent with the underlying pathophysiology or progression of underlying disease, as SAEs.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place