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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2914 |
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Date of registration:
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24/05/2011 |
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Primary sponsor: |
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Public title:
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Glutamine metabolism in surgical patients.
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Scientific title:
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The metabolic pathway of glutamine citrulline and arginine in surgical patients. - DIPEP HUMAN SURG |
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Date of first enrolment:
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1/3/2011 |
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Target sample size:
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15 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2914 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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P.A.M.
Leeuwen, van |
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Address:
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P.O. Box 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4440042 |
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Email:
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pam.vleeuwen@vumc.nl |
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Affiliation:
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Name:
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M.A.R.
Vermeulen |
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Address:
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VU Medisch Centrum
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4445370 |
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Email:
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mar.vermeulen@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients undergoing aortic replacement surgery for abdominal aneurysm;
2. Age: > 35 and < 70 years;
3. BMI < 35;
4. Having obtained his/her informed consent.
Exclusion criteria: 1. Patients not fit for surgery as decided by the anesthesiology department (renal/hepatic insufficiency or heart failure);
2. Hepatitis, severe cirrhosis, urea cycle disorders/citrullinemia;
3. Kidney failure;
4. Pregnancy;
5. Corticosteroids intake in the last 4 weeks;
6. Insulin dependent diabetes mellitus;
7. Celiac disease, Crohn?s disease or other major intestinal malabsorption disorder.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Enteral nutrition, Metabolic route, Glutamine, Citrulline, Arginine, alanyl-glutamine, Abdominal Aortic Aneurysm, Ischemia reperfusion injury, Kidney, Aortic surgery
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Intervention(s)
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Group A and B: 5 patients will receive a primed continuous infusion of 0.5 g/kg/24hr L-alanyl-L-glutamine intravenously, starting 12 hours before surgery.
Group C (control group): Patients do not receive L-alanyl-L-glutamine.
Each group will receive stable isotopes of glutamine, citrulline, arginine, phenylalanine and tyrosine intravenously.
Group A will receive the tracers during surgery, but before aortic clamping. Group B and C wil receive the tracers after surgery.
A renal venous blood sample will be taken during surgery but before aortic clamping.
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Primary Outcome(s)
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The whole body rate of appearance of glutamine, citrulline and arginine, as well as the conversion of intravenously supplied glutamine into citrulline and arginine at the whole body level.
Furtermore, renal turnover of citrulline into arginine in patients receiving L-alanyl-L-glutamine.
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Secondary Outcome(s)
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The quantitative effect of aortic surgery on arginine metabolism in patients treated with or without L-alanyl-L-glutamine.
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Source(s) of Monetary Support
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VU University Medical Center
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