Immunonutrition in Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT00247793|
Recruitment Status : Completed
First Posted : November 2, 2005
Last Update Posted : November 2, 2005
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|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
- Postoperative infectious morbidity
- Immunological measurements
- Postoperative organ function/support
- Recovery (Length of ICU stay, postoperative length of hospital stay)
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
|Cardiopulmonary Surgery, Academic Medical Center|
|Amsterdam, NH, Netherlands, 1105 AZ|
|Principal Investigator:||Leon Eijsman, MD, PhD||Director department of cardiopulmonary surgery|