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 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 trial start date
01/05/1996
Overall trial end date
01/11/1997
Reason abandoned (if study stopped)
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
Funders
Funder type
Industry
Funder name
Novartis (Switzerland)
Alternative name(s)
Novartis AG, Novartis International AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11551575
Publication citations
-
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.