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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
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorders focused on measuring Nutrition Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    August 23, 2016
    Last Updated
    September 15, 2016
    Sponsor
    Universitair Ziekenhuis Brussel
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    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

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    The CoCoS Interventional Trial: Caloric Control in Cardiac Surgery Patients

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