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 number	NCT00247793
Secondary identifying numbers	NTR450; 96.17.066

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Robert Tepaske
Scientific

Academic Medical Center
Department of Intensive Care, C3-324
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Email	r.tepaske@amc.uva.nl

Study design	Multicentre prospective randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Postoperative morbidity e.g. infectious morbidity and organ (dys)function
Secondary outcome measures	Immunological parameters (inflammatory response) ICU and hospital stay of length
Overall study start date	01/05/1996
Completion date	01/11/1997

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

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

"ROR"	https://ror.org/03t4gr691

Industry

Novartis (Switzerland)
Government organisation / For-profit companies (industry)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2001		Yes	No