search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The effect of pre- and postoperative supplemental enteral nutrition in high-risk patiens undergoing elective cardiac surgery. A prospective randomized placebo controlled double blind multicenter trial.


- candidate number1746
- NTR NumberNTR450
- ISRCTNISRCTN37657221
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR6-okt-2005
- Secondary IDs96.17.066 
- Public TitleThe effect of pre- and postoperative supplemental enteral nutrition in high-risk patiens undergoing elective cardiac surgery. A prospective randomized placebo controlled double blind multicenter trial.
- Scientific TitleThe effect of pre- and postoperative supplemental enteral nutrition in high-risk patiens undergoing elective cardiac surgery. A prospective randomized placebo controlled double blind multicenter trial.
- ACRONYMIMPACT II
- hypothesisTo study the effects of a pre-operative supplemental enteral feeding with IMPACT® on the systemic inflammatory response to cardiopulmonary bypass and on immunological parameters will be examined.
- Healt Condition(s) or Problem(s) studiedElective cardiac surgery
- Inclusion criteriaPatients aged >= 70 years undergoing coronary bypass grafting, or pre-operative fraction < 0.40 or patients undergoing mitral valve replacements or combinations.
- Exclusion criteria1. Age <21 years;
2. Pregnancy;
3. Insulin depedent diabetes mellitus;
4. Hepatic cirrhosis;
5. Known malignancy;
6. Use of chemotherapy, NSAIDs or corticosteroids;
7. Schizophrenia;
8. Severe renal failure;
9. Patients with organ transplantation in the past.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-1996
- planned closingdate1-nov-1997
- Target number of participants74
- InterventionsAll patients receive an oral nutritional supplement for at least 5 days with a maximum of 10 days before their operation in addition to their normal diet. One treatment group received a supplement that was enriched with arginine, omega-3 PUFAs and nucleotides compared to the control. The other treatment group received a supplement that was further enriched with glycine compared with the first treatment group. Patients that needed enteral nutrition postoperatively received a formula that was comparable with the preoperative supplement.
- Primary outcomePostoperative morbidity, e.g. infectious morbidity & organ (dys)function.
- Secondary outcome1. Immunological parameters (inflammatory response);
2. ICU and hospital stay of length.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Robert Tepaske
- CONTACT for SCIENTIFIC QUERIES Robert Tepaske
- Sponsor/Initiator Academic Medical Center (AMC), Department of Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
Novartis Nutrition
- PublicationsJPEN J Parenter Enteral Nutr. 2007 May-Jun;31(3):173-80.


Abstract NESPEN, december 2004.
- Brief summaryPreoperative oral immune enhancing nutritional supplement reduces postoperative infectious morbidity and results in a more stable circulation; the addition of glycine does not result in any benificial effect over standard oral immune enhancing nutritional supplement.
- Main changes (audit trail)
- RECORD6-okt-2005 - 28-aug-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl