Immunonutrition in Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT00247793
First received: November 1, 2005
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

Effect of two preoperative oral immune-enhancing nutritional supplements in patients at high risk of infection after cardiac surgery: a randomized placebo-controlled study.

Introduction: In our first study we showed that the use of a preoperative oral immune-enhancing nutritional supplement (OIENS) resulted in an improved patients’ host-defence with a reduction in postoperative infectious morbidity in ‘high-risk’ cardiac surgery patients. The use of the OIENS resulted also in less postoperative organ dysfunction. Experimental studies have shown that additional glycine results in less ischemia-reperfusion damage and that glycine has anti-inflammatory properties.

Objective: The use of an OIENS in the preoperative period in patients at high risk of infection after elective cardiac surgery with the use of cardiopulmonary bypass (CPB) results in a reduction in infections as in our first study. The addition of 9.6 gram glycine per sachet OIENS results in a further reduction in postoperative dysfunction.

Design: A prospective randomized placebo controlled study with two oral immune enhancing nutritional formula’s and an isocaloric control formula. Patients: Seventy-four consecutive patients undergoing cardiac surgery with the use of an CPB who met one or more of the following inclusion criteria: Age 70 years or older, mitral valve replacement or cardiac ejection fraction less then 40%. Exclusion criteria were age < 18 years, proven malignancy, use of corticosteroids, severe renal and liver failure. Definition of a protocol violation was the intake of less then 5 L or more then 10 L of the nutritional supplement in the preoperative period.

Intervention: Patients were split up in three groups by concealed randomisation. One group received the arginine, omega3-PUFAs and nucleotides enriched formula (OIENS). Another group received the OIENS further enriched with glycine (OIENS+glyc). The control group received an isocaloric nutritional supplement without the enrichments.


Condition Intervention
Thoracic Surgery
Cardiac Surgery
Cardiopulmonary Bypass
Drug: Oral Impact (preoperative enteral nutritional supplement)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Pre- and Postoperative Supplemental Enteral Nutrition in High-Risk Patients Undergoing Elective Cardiac Surgery. A Prospective Double Blind Study.

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Postoperative infectious morbidity
  • Mortality

Secondary Outcome Measures:
  • Immunological measurements
  • Postoperative organ function/support
  • Recovery (Length of ICU stay, postoperative length of hospital stay)

Study Start Date: July 1996
Estimated Study Completion Date: December 1998
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients undergoing cardiac surgery with the use of cardiopulmonary bypass, who met one of the following criteria

  • age >= 70 years
  • poor left ventricular function (ejection fraction < 0.4)
  • mitral valve replacement

Exclusion Criteria:

  • Age =< 21 years
  • Pregnancy
  • Insulin dependent diabetes mellitus
  • Hepatic Cirrhosis
  • Known malignancy
  • Use of chemotherapy, NSAIDs (except ASA), or corticosteroids
  • Schizophrenia
  • Severe renal failure (creatinine clearance < 25 mL/h) before study entrance
  • Patients with an organ transplantation in the past
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247793

Locations
Netherlands
Cardiopulmonary Surgery, Academic Medical Center
Amsterdam, NH, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Leon Eijsman, MD, PhD Director department of cardiopulmonary surgery
  More Information

Publications:
Beale RJ, Schneider H, Sorensen f, Smithies MN, Bennet ED, Bihari DJ. A multicentre randomised, controlled trial comparing enteral feeding with IMPACT versus IMPACT with Glycine. Intensive Care Medicine 26(suppl 3):S300,2000
Tepaske R. Nutritional supplementation after cardiac surgery. Lancet 359(9302):257-8,2002

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00247793     History of Changes
Other Study ID Numbers: 96.17.066, Mec 95/232
Study First Received: November 1, 2005
Last Updated: November 1, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
immunonutrition
preoperative optimization
preoperative enteral nutritional supplement
high risk
cardiac surgery
arginine
omega-3 polyunsaturated fatty acids
nucleotides
glycine
immune enhancing nutritional supplement
immune enhancing formula

ClinicalTrials.gov processed this record on April 15, 2014