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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.
Register: Netherlands Trial Register
Last refreshed on: 28 April 2013
Main ID:  NTR2914
Date of registration: 24/05/2011
Primary sponsor: VU University Medical Center
Public title: Glutamine metabolism in surgical patients.
Scientific title: The metabolic pathway of glutamine citrulline and arginine in surgical patients. - DIPEP HUMAN SURG
Date of first enrolment: 1/3/2011
Target sample size: 15
Recruitment status: recruiting
URL:  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2914
Study type:  intervention
Study design:  Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized  
Countries of recruitment
The Netherlands
Contacts
Name: P.A.M.  Leeuwen, van
Address:  P.O. Box 7057 1007 MB Amsterdam The Netherlands
Telephone: +31 (0)20 4440042
Email: pam.vleeuwen@vumc.nl
Affiliation: 
Name: M.A.R.  Vermeulen
Address:  VU Medisch Centrum Amsterdam The Netherlands
Telephone: +31 (0)20 4445370
Email: mar.vermeulen@vumc.nl
Affiliation: 
Key inclusion & exclusion criteria
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:
Health Condition(s) or Problem(s) studied
Enteral nutrition, Metabolic route, Glutamine, Citrulline, Arginine, alanyl-glutamine, Abdominal Aortic Aneurysm, Ischemia reperfusion injury, Kidney, Aortic surgery

Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
The quantitative effect of aortic surgery on arginine metabolism in patients treated with or without L-alanyl-L-glutamine.
Secondary ID(s)
2002-150
Source(s) of Monetary Support
VU University Medical Center
Secondary Sponsor(s)
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