The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

Study Overview
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Brief Summary
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Background: Malnutrition is widespread among cardiac surgery patients and is independently related to an adverse postoperative evolution or outcome. The investigators aimed to assess whether nutrition therapy (NT) could alter caloric deficit, morbidity, and mortality in patients scheduled for non-emergency coronary artery bypass graft (CABG) or aortic valve surgery. Methods: 351 patients undergoing either elective CABG or aortic valve surgery were studied. Patients receiving NT were enrolled from January 2013 until December 2014. A historical control group consisted of 142 matched patients. Preoperative nutritional status was evaluated. Resting energy expenditure was measured using indirect calorimetry or calculated. Caloric intake and caloric deficits were assessed. The primary endpoint was to evaluate whether NT could limit caloric deficit (Intake to Need Deviation). A secondary endpoint addressed the potential effect of NT on morbidity and mortality. Patients were followed for one year after surgery.

Detailed Description
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Background: Malnutrition, often presenting as sarcopenic obesity, is widespread among cardiac surgery patients and is independently related to an adverse postoperative evolution or outcome. Nutritional status and energetic needs or deficits in cardiac surgery patients are poorly documented and undernutrition, though readily modifiable, is an often overlooked condition during hospitalization. The investigators aimed to assess whether nutrition therapy (NT) could alter caloric deficit, morbidity, and mortality in patients scheduled for non-emergency coronary artery bypass graft (CABG) or aortic valve surgery. Methods: 351 patients undergoing either elective CABG or aortic valve surgery were studied. Patients receiving NT were enrolled from January 2013 until December 2014. A historical control group consisted of 142 matched patients who underwent either type of surgery. In all patients, the NRS 2002 and MUST score were used for evaluating the preoperative nutritional status. Resting energy expenditure was measured using indirect calorimetry or calculated. A dietician assessed daily caloric intake during the entire hospitalization. Caloric deficits were calculated. According to a predefined flow-chart protocol, nutritional interventions were launched on different time points. Interventions varied from nutritional modifications to oral supplementation, tube feeding, and parenteral nutrition. The primary endpoint was to evaluate whether NT could limit caloric deficit (Intake to Need Deviation). A secondary endpoint addressed the potential effect of NT on morbidity and mortality. Patients were followed for one year after surgery.

Official Title
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The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

Conditions
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Metabolism and Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Nutrition Therapy
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients scheduled for conventional non-urgent cardiac surgery type coronary artery bypass graft (CABG) or aortic valve surgery Exclusion Criteria: urgent surgery aortic arch surgery or other cardiac surgery procedures requiring sternotomy off-pump cardiac surgery preoperative hemodynamic instability pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Standard protocol nutrition. | Dietary Supplement: Control<br>* Standard protocol nutrition based on calculated caloric needs.<br>|
| Experimental: Nutrition Therapy<br>Resting energy expenditure was measured using indirect calorimetry or calculated. A dietician assessed daily caloric intake during the entire hospitalization. Caloric deficits were calculated. According to a predefined flow-chart protocol, nutritional interventions were launched on different time points. Interventions varied from nutritional modifications to oral supplementation, tube feeding, and parenteral nutrition. | Dietary Supplement: Nutrition Therapy<br>* Nutrition based on measured caloric needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery |  | 3 months (measured at intervals) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition Therapy