Immunonutrition in Cardiac Surgery

NCT00247793 | Completed

• 2 other identifiers: 96.17.066Mec 95/232
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Cardiac Surgery; Cardiopulmonary Bypass

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Postoperative infectious morbidity

• Mortality

Secondary Outcomes (3)

• Immunological measurements

• Postoperative organ function/support

• Recovery (Length of ICU stay, postoperative length of hospital stay)

Interventions

Oral Impact (preoperative enteral nutritional supplement) DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Cardiopulmonary Surgery, Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (41)

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  BACKGROUND

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  PMID: 17463141 DERIVED

Study Officials

• Leon Eijsman, MD, PhD

  Director department of cardiopulmonary surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 2, 2005
• Study Start: July 1, 1996
• Study Completion: December 1, 1998
• Last Updated: November 2, 2005

Record last verified: 2005-11

Locations

NL (1)