Condition category
Surgery
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Tepaske

ORCID ID

Contact details

Academic Medical Center
Department of Intensive Care
C3-324
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
r.tepaske@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00247793

Protocol/serial number

NTR450; 96.17.066

Study information

Scientific title

Acronym

IMPACT II

Study hypothesis

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

Received from local medical ethics committee

Study design

Multicentre prospective randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Postoperative morbidity e.g. infectious morbidity and organ (dys)function

Secondary outcome measures

Immunological parameters (inflammatory response)
ICU and hospital stay of length

Overall trial start date

01/05/1996

Overall trial end date

01/11/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged ≥70 years undergoing coronary bypass grafting, or pre-operative fraction <0.40 or patients undergoing mitral valve replacements or combinations

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

74

Participant 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

Recruitment start date

01/05/1996

Recruitment end date

01/11/1997

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Intensive Care
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Novartis (Switzerland)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11551575

Publication citations

  1. Results

    Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eÿsman L, Kesecioglu J, Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial., Lancet, 2001, 358, 9283, 696-701.

Additional files

Editorial Notes