No registrations found.
ID
Source
Brief title
Health condition
High risk patients undergoing elective cardiac surgery.
Sponsors and support
Bern
Switzerland
Intervention
Outcome measures
Primary outcome
Postoperative morbidity, e.g. infectious morbidity & organ (dys)function.
Secondary outcome
1. Immunological parameters (inflammatory response);
2. ICU and hospital stay of length.
Background summary
Preoperative 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.
Study objective
To 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.
Study design
N/A
Intervention
All 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.
P.O. Box 22660
Robert Tepaske
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.tepaske@amc.uva.nl
P.O. Box 22660
Robert Tepaske
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.tepaske@amc.uva.nl
Inclusion criteria
Patients aged >= 70 years undergoing coronary bypass grafting, or pre-operative fraction < 0.40 or patients undergoing mitral valve replacements or combinations.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL410 |
| NTR-old | NTR450 |
| Other | : 96.17.066 |
| ISRCTN | ISRCTN37657221 |
Summary results
<br><br>
Abstract NESPEN, december 2004.<br>