The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Metabolism and Nutrition Disorders

Treatments: Dietary Supplement: Nutrition Therapy; Dietary Supplement: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02902341

2012/045

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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351 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard protocol nutrition.

Treatment:

Dietary Supplement: Control

Nutrition Therapy

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutrition Therapy