Trial Outcomes & Findings for Efficacy and Mechanisms of GLN Dipeptide in the SICU (NCT NCT00248638)
NCT ID: NCT00248638
Last Updated: 2018-01-23
Results Overview
Number of participants who died during hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Current Hospitalization (Up to 6 Months)
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
Glutamine Dipeptide
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Mechanisms of GLN Dipeptide in the SICU
Baseline characteristics by cohort
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
Total
n=150 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
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
60.3 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Current Hospitalization (Up to 6 Months)Number of participants who died during hospitalization.
Outcome measures
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Hospital Mortality Rate
|
11 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Current Hospitalization (Up to 6 Months)Subjects remaining infection-free during the hospitalization.
Outcome measures
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Percentage of Patients Who do Not Develop Hospital Infections
|
56 percentage of participants
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28Population: The number of participants currently hospitalized are included in each time point analysis.
Glutathione (GSH) levels will be measured in µM (micro moles) from baseline to day 28. Higher levels indicate a higher GSH presence.
Outcome measures
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Mean Glutathione Level
Baseline
|
1.850 µM
Standard Deviation .195
|
1.880 µM
Standard Deviation .182
|
|
Mean Glutathione Level
Day 3
|
1.524 µM
Standard Deviation .156
|
1.374 µM
Standard Deviation .162
|
|
Mean Glutathione Level
Day 7
|
5.056 µM
Standard Deviation 3.619
|
1.473 µM
Standard Deviation .202
|
|
Mean Glutathione Level
Day 14
|
1.312 µM
Standard Deviation .220
|
1.327 µM
Standard Deviation .306
|
|
Mean Glutathione Level
Day 21
|
1.286 µM
Standard Deviation .266
|
1.597 µM
Standard Deviation .297
|
|
Mean Glutathione Level
Day 28
|
1.279 µM
Standard Deviation .232
|
1.430 µM
Standard Deviation .301
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28Population: The number of participants currently hospitalized are included in each time point analysis.
Levels of the heat shock protein,HSP70, will be measured in ng/mL from baseline to day 28. Higher levels indicate a higher protein presence.
Outcome measures
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Mean Heat Shock Proteins Level, HSP70
Baseline
|
52.6 ng/mL
Standard Deviation 6.2
|
55.3 ng/mL
Standard Deviation 8.7
|
|
Mean Heat Shock Proteins Level, HSP70
Day 3
|
48.1 ng/mL
Standard Deviation 6.0
|
44.5 ng/mL
Standard Deviation 5.8
|
|
Mean Heat Shock Proteins Level, HSP70
Day 7
|
52.1 ng/mL
Standard Deviation 7.0
|
36.4 ng/mL
Standard Deviation 3.1
|
|
Mean Heat Shock Proteins Level, HSP70
Day 14
|
33.9 ng/mL
Standard Deviation 4.6
|
33.9 ng/mL
Standard Deviation 4.0
|
|
Mean Heat Shock Proteins Level, HSP70
Day 21
|
30.7 ng/mL
Standard Deviation 4.0
|
32.9 ng/mL
Standard Deviation 6.7
|
|
Mean Heat Shock Proteins Level, HSP70
Day 28
|
26.3 ng/mL
Standard Deviation 3.1
|
25.5 ng/mL
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, Day 3, Day 7, Day 14, Day 21, Day 28Population: The number of participants currently hospitalized are included in each time point analysis.
Levels of the heat shock protein, HSP27, will be measured in pg/mL from baseline to day 28. Higher levels indicate a higher protein presence.
Outcome measures
| Measure |
Glutamine Dipeptide
n=75 Participants
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 Participants
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Mean Heat Shock Proteins Level, HSP27
Baseline
|
1171.1 pg/mL
Standard Deviation 70.9
|
1134.3 pg/mL
Standard Deviation 76.0
|
|
Mean Heat Shock Proteins Level, HSP27
Day 3
|
1189.3 pg/mL
Standard Deviation 68.9
|
1140.0 pg/mL
Standard Deviation 71.1
|
|
Mean Heat Shock Proteins Level, HSP27
Day 7
|
1222.4 pg/mL
Standard Deviation 82.0
|
1259.0 pg/mL
Standard Deviation 91.5
|
|
Mean Heat Shock Proteins Level, HSP27
Day 14
|
1161.0 pg/mL
Standard Deviation 98.7
|
1253.4 pg/mL
Standard Deviation 107.1
|
|
Mean Heat Shock Proteins Level, HSP27
Day 21
|
1314.3 pg/mL
Standard Deviation 119.7
|
1250.9 pg/mL
Standard Deviation 163.2
|
|
Mean Heat Shock Proteins Level, HSP27
Day 28
|
1177.5 pg/mL
Standard Deviation 137.8
|
880.9 pg/mL
Standard Deviation 144.9
|
Adverse Events
Glutamine Dipeptide
Serious events: 39 serious events
Other events: 22 other events
Deaths: 11 deaths
Standard
Serious events: 40 serious events
Other events: 12 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Glutamine Dipeptide
n=75 participants at risk
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 participants at risk
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
General disorders
death
|
20.0%
15/75 • Number of events 15 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
25.3%
19/75 • Number of events 19 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
|
Surgical and medical procedures
rehospitalization
|
20.0%
15/75 • Number of events 16 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
17.3%
13/75 • Number of events 15 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
|
Surgical and medical procedures
re-operation within 30 days
|
21.3%
16/75 • Number of events 30 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
18.7%
14/75 • Number of events 28 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
Other adverse events
| Measure |
Glutamine Dipeptide
n=75 participants at risk
Glutamine dipeptide supplemented nutrition to be given to participants.
|
Standard
n=75 participants at risk
Participants given standard nutrition without glutamine dipeptide
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
respiratory distress
|
17.3%
13/75 • Number of events 14 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
14.7%
11/75 • Number of events 14 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
|
Respiratory, thoracic and mediastinal disorders
tracheostomy
|
29.3%
22/75 • Number of events 22 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
16.0%
12/75 • Number of events 12 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
|
General disorders
significant bleeding
|
12.0%
9/75 • Number of events 11 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
8.0%
6/75 • Number of events 7 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
|
General disorders
ICU readmission
|
18.7%
14/75 • Number of events 16 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
13.3%
10/75 • Number of events 13 • Adverse events were collected throughout each participant's hospital stay (up to six months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place