The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

Metabolism and Nutrition Disorders Clinical Trial

Official title:

The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902341
• Other study ID #: 2012/045
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: September 15, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorders
• Nutrition Disorders

Intervention

Dietary Supplement:
• Nutrition Therapy
Nutrition based on measured caloric needs.
• Control
Standard protocol nutrition based on calculated caloric needs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

References & Publications (1)

De Waele E, Mattens S, Honoré PM, Spapen H, De Grève 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery		3 months (measured at intervals)	Yes
Secondary	Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year		1 year	Yes