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Immunonutrition in Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00247793
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : November 2, 2005
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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 or disease Intervention/treatment Phase
Thoracic Surgery Cardiac Surgery Cardiopulmonary Bypass Drug: Oral Impact (preoperative enteral nutritional supplement) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : July 1996
Study Completion Date : December 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Primary Outcome Measures :
  1. Postoperative infectious morbidity
  2. Mortality

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00247793

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00247793    
Other Study ID Numbers: 96.17.066
Mec 95/232
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: November 2, 2005
Last Verified: November 2005
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
preoperative optimization
preoperative enteral nutritional supplement
high risk
cardiac surgery
omega-3 polyunsaturated fatty acids
immune enhancing nutritional supplement
immune enhancing formula