Clinical trial NCT02902341: The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients
Official title: The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism and Nutrition Disorders
Keywords: Nutrition Therapy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery
timeFrame: 3 months (measured at intervals)
Secondary outcomes:
measure: Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: UZ Brussel (Vrije Universiteit Brussel)
name: Elisabeth De Waele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Waele E, Mattens S, Honore PM, Spapen H, De Greve J, Pen JJ. Nutrition therapy in cachectic cancer patients. The Tight Caloric Control (TiCaCo) pilot trial. Appetite. 2015 Aug;91:298-301. doi: 10.1016/j.appet.2015.04.049. Epub 2015 Apr 22.
citation: De Waele E, Nguyen D, De Bondt K, La Meir M, Diltoer M, Honore PM, Spapen H, Pen JJ. The CoCoS trial: Caloric Control in Cardiac Surgery patients promotes survival, an interventional trial with retrospective control. Clin Nutr. 2018 Jun;37(3):864-869. doi: 10.1016/j.clnu.2017.03.007. Epub 2017 Mar 18.