Trial Outcomes & Findings for Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension (NCT NCT01048905)
NCT ID: NCT01048905
Last Updated: 2021-06-10
Results Overview
Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-06-10
Participant Flow
Participant milestones
| Measure |
Treatment: L-glutamine
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood work only available for N=6 participants, as reported here.
Baseline characteristics by cohort
| Measure |
Treatment: L-glutamine
n=13 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 13.8 • n=13 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
|
Erythrocyte Glutamine/Glutamate Ratio
|
1.75 Ratio
STANDARD_DEVIATION 0.6 • n=6 Participants • Blood work only available for N=6 participants, as reported here.
|
|
Plasma Glutamine
|
704.5 µmol/L
STANDARD_DEVIATION 137 • n=6 Participants • Blood work only available for N=6 participants, as reported here.
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|
Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography
|
3.0 Meters per second
STANDARD_DEVIATION 0.6 • n=13 Participants
|
|
6 Minute Walk Distance
|
386 Meters
STANDARD_DEVIATION 94 • n=13 Participants
|
|
Liver Function Tests
Alanine aminotransferase (ALT)
|
40 U/L
STANDARD_DEVIATION 42 • n=13 Participants
|
|
Liver Function Tests
Aspartate aminotransferase (AST)
|
73 U/L
STANDARD_DEVIATION 40 • n=13 Participants
|
|
Renal Function Tests
Creatinine
|
0.9 mg/dL
STANDARD_DEVIATION 0.4 • n=13 Participants
|
|
Renal Function Tests
Blood urea nitrogen (BUN)
|
14 mg/dL
STANDARD_DEVIATION 10 • n=13 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Blood work only available for N=6 participants, as reported here.
Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress
Outcome measures
| Measure |
Treatment: L-glutamine
n=6 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks
|
2.40 Ratio
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Treatment: L-glutamine
n=12 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Plasma Glutamine
|
685.8 µmol/L
Standard Deviation 139
|
SECONDARY outcome
Timeframe: 8 weekPopulation: Data available for 11 participants only because one patient missed their appointment for their week 8 echocardiogram and was lost to follow up, and another patient died of sepsis before week 8 visit.
Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second.
Outcome measures
| Measure |
Treatment: L-glutamine
n=11 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography
|
2.8 Meters per second
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 8 weeksThe six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface.
Outcome measures
| Measure |
Treatment: L-glutamine
n=12 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
6 Minute Walk Distance
|
366 Meters
Standard Deviation 109
|
SECONDARY outcome
Timeframe: 8 weeksAlanine aminotransferase (ALT) Aspartate aminotransferase (AST)
Outcome measures
| Measure |
Treatment: L-glutamine
n=12 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Liver Function Tests
ALT
|
38 U/L
Standard Deviation 27
|
|
Liver Function Tests
AST
|
63 U/L
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 8 weeksCreatinine Blood urea nitrogen (BUN)
Outcome measures
| Measure |
Treatment: L-glutamine
n=12 Participants
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
|
Renal Function Tests
BUN
|
17 mg/dL
Standard Deviation 7
|
|
Renal Function Tests
Creatinine
|
0.9 mg/dL
Standard Deviation 0.3
|
Adverse Events
Treatment: L-glutamine
Serious events: 4 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment: L-glutamine
n=13 participants at risk
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
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General disorders
Pain
|
23.1%
3/13 • 8 weeks
|
|
General disorders
Acute Chest Syndrome
|
7.7%
1/13 • 8 weeks
|
|
Infections and infestations
Sepsis
|
7.7%
1/13 • 8 weeks
|
Other adverse events
| Measure |
Treatment: L-glutamine
n=13 participants at risk
Patients will receive an 8-week course of oral L-glutamine 10 grams TID
L-Glutamine: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.
|
|---|---|
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Reproductive system and breast disorders
Sexually Transmitted Disease Related Pain
|
7.7%
1/13 • 8 weeks
|
Additional Information
Claudia R. Morris MD, FAAP
Emory University School of Medicine
Phone: 404-727-5500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place