|- candidate number||7689|
|- NTR Number||NTR2183|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-jan-2010|
|- Secondary IDs||NL2823.013.09 / 09/304 CCMO / MEC|
|- Public Title||The effect of nutrition in cardiac surgical patients on heart function.|
|- Scientific Title||The effect of perioperative (par)enteral nutrition on amino acid profile, cardiomyocytes functioning, and cardiac perfusion and metabolism of the cardiac surgical patient.|
|- hypothesis||We hypothesize that there is a disturbed amino acids profile in the cardiac surgical patient and that nutrition during surgery will normalize this profile with a subsequent improvement in cardiomyocytes functioning by histology, and in cardiac perfusion and metabolism.|
|- Healt Condition(s) or Problem(s) studied||Heart failure, Coronary artery disease|
|- Inclusion criteria||1. Patients who have to undergo an off-pump coronary artery bypass grafting (CABG) operation;|
2. Aged 18 till 81 years.
|- Exclusion criteria||1. Combined valve and CABG procedures;|
2. Aged <18 and > 80 years;
3. Diabetes mellitus type I;
5. Renal insufficiency defined as creatinine > 95 micromol/L for women and > 110 micromol/L for men;
6. Liver insufficiency defined as alanine aminotransferase > 34 U/I for women and > 45 U/I for men.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-okt-2010|
|- Target number of participants||48|
|- Interventions||Our patients will be given enteral nutrition (n=16), peripheral parenteral nutrition (n=16) or a saline solution (control) (n=16) at least three days before, during, and one day after CABG. Both enteral and parenteral nutrition are mixtures of amino acids, glucose, lipids, vitamins, and minerals. |
|- Primary outcome||The main study outcomes are concentrations of amino acids, and methylated arginines in blood plasma and cardiac tissue, and cardiomyocytes functioning assessed by histology. |
|- Secondary outcome||The secondary study outcomes are cardiac perfusion, and cardiac fatty acid and glucose metabolism, measured by myocardial scintigraphy and positron emission tomography.|
|- Timepoints||Blood samples will be taken before, during and after surgery.
Cardiac tissue samples will be collected during surgery.
Myocardial scintigraphy, and a PET-scan will be performed at baseline and 3 weeks after surgery.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD B.A.J.M. Mol, de|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD P.A.M. Leeuwen, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Malnutrition is very common in patients undergoing cardiac surgery as well as other types of surgery. For example, in a population of cardiac and abdominal surgical patients, respectively 9.1% and 44% was malnourished. Malnutrition can change myocardial substrate utilization which can induce adverse effects on myocardial metabolism. Interestingly, malnutrition is an underlying risk factor for the perioperative cardiac complications seen in patients undergoing non-cardiac surgery. Therefore, by optimizing nutritional status of (cardiac) surgical patients, cardiac metabolism and function might be improved. This can be done by administration of enteral or parenteral feeding.
Our primary objective is to evaluate the effect of perioperative enteral and peripheral parenteral nutrition on amino acid profile and cardiomyocytes functioning of cardiac surgical patients. Our secondary objective is to study the effect of (par)enteral nutrition on cardiac perfusion, and fatty acid and glucose metabolism. We hypothesize that there is a disturbed amino acids profile in the cardiac surgical patient and that nutrition during surgery will normalize this profile with a subsequent improvement in cardiomyocytes functioning by histology, and in cardiac perfusion and metabolism.
This proof-of-concept will be investigated in a randomized controlled intervention study.
Our research population will consist of 48 patients undergoing cardiac surgery for coronary artery bypass grafting (CABG) at the department of cardio-thoracic surgery at the Academic Medical Center University of Amsterdam.
Our patients will be given enteral nutrition (n=16), peripheral parenteral nutrition (n=16) or a saline solution (control) (n=16) at least three days before, during, and one day after CABG. Both enteral and parenteral nutrition are mixtures of amino acids, glucose, lipids, vitamins, and minerals.
Main study parameters/endpoints:
We will illustrate the effect of nutrition by differences in amino acids concentrations in blood plasma and cardiac tissue, and in cardiomyocytes functioning between the (par)enteral and control group. In addition, differences in cardiac perfusion, and fatty acid and glucose metabolism between the (par)enteral and control group will be evaluated by myocardial scintigraphy with the tracer technium99m-tetrofosmine (99mTc-tetrofosmine), by myocardial scintigraphy with beta-methyl-p-[123I]-iodophenyl-pentadecanoic acid (123IBMIPP), and by using positron emission tomography (PET) with the tracer F18-fluorodeoxy-glucose (18FFDG) respectively.
|- Main changes (audit trail)|
|- RECORD||26-jan-2010 - 6-okt-2012|