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Immunonutrition in Cardiac Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247793
First Posted: November 2, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  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
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 1, 2005
First Posted: November 2, 2005
Last Update Posted: December 9, 2005
Last Verified: November 2005

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