The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients
Primary Purpose
Metabolism and Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutrition Therapy
Control
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorders focused on measuring Nutrition Therapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Nutrition Therapy
Arm Description
Standard protocol nutrition.
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.
Outcomes
Primary Outcome Measures
Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery
Secondary Outcome Measures
Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year
Full Information
NCT ID
NCT02902341
First Posted
August 23, 2016
Last Updated
September 15, 2016
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02902341
Brief Title
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorders
Keywords
Nutrition Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard protocol nutrition.
Arm Title
Nutrition Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition Therapy
Intervention Description
Nutrition based on measured caloric needs.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Standard protocol nutrition based on calculated caloric needs.
Primary Outcome Measure Information:
Title
Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery
Time Frame
3 months (measured at intervals)
Secondary Outcome Measure Information:
Title
Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth De Waele, MD, PhD
Organizational Affiliation
UZ Brussel (Vrije Universiteit Brussel)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication without revealing patient ID's.
Citations:
PubMed Identifier
25912786
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.
Results Reference
background
PubMed Identifier
28365080
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.
Results Reference
derived
Learn more about this trial
The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients
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