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The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

NCT02902341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2016-09-16

No results posted yet for this study

Summary

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.

Conditions

  • Metabolism and Nutrition Disorders

Interventions

DIETARY_SUPPLEMENT

Nutrition Therapy

Nutrition based on measured caloric needs.

DIETARY_SUPPLEMENT

Control

Standard protocol nutrition based on calculated caloric needs.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Elisabeth De Waele, MD, PhD · UZ Brussel (Vrije Universiteit Brussel)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902341 on ClinicalTrials.gov