Cardiac Surgery Clinical Trial
Official title:
The Effect of Pre- and Postoperative Supplemental Enteral Nutrition in High-Risk Patients Undergoing Elective Cardiac Surgery. A Prospective Double Blind Study.
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 1998 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Cardiopulmonary Surgery, Academic Medical Center | Amsterdam | NH |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative infectious morbidity | |||
Primary | Mortality | |||
Secondary | Immunological measurements | |||
Secondary | Postoperative organ function/support | |||
Secondary | Recovery (Length of ICU stay, postoperative length of hospital stay) |
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