The effect of pre- and post-operative supplemental enteral nutrition in high-risk patients undergoing elective cardiac surgery. A prospective randomised placebo controlled double blind multicentre trial.
| ISRCTN | ISRCTN37657221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37657221 |
| ClinicalTrials.gov (NCT) | NCT00247793 |
| Protocol serial number | NTR450; 96.17.066 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Novartis (Switzerland) |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Tepaske
Scientific
Scientific
Academic Medical Center
Department of Intensive Care, C3-324
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
| r.tepaske@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre prospective randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | IMPACT II |
| Study objectives | 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. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | High risk patients undergoing elective cardiac surgery |
| 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 post-operatively received a formula that was comparable with the pre-operative supplement. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Postoperative morbidity e.g. infectious morbidity and organ (dys)function |
| Key secondary outcome measure(s) |
Immunological parameters (inflammatory response) |
| Completion date | 01/11/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 74 |
| Key inclusion criteria | Patients aged ≥70 years undergoing coronary bypass grafting, or pre-operative fraction <0.40 or patients undergoing mitral valve replacements or combinations |
| Key exclusion criteria | 1. Age <21 years 2. Pregnancy 3. Insulin dependent 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 |
| Date of first enrolment | 01/05/1996 |
| Date of final enrolment | 01/11/1997 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2001 | Yes | No |
