NCT02902341

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
351

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

August 23, 2016

Last Update Submit

September 15, 2016

Conditions

Metabolism and Nutrition Disorders

Keywords

Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with limitation of caloric deficit (Intake to Need Deviation) during hospital stay after cardiac surgery

    3 months (measured at intervals)

Secondary Outcomes (1)

  • Number of participants with overall survival at 1 year or morbidity (acute heart failure, arrythmia, sepsis or pneumonia) during 1 year

    1 year

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard protocol nutrition.

Dietary Supplement: Control

Nutrition Therapy

EXPERIMENTAL

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.

Dietary Supplement: Nutrition Therapy

Interventions

Nutrition TherapyDIETARY_SUPPLEMENT

Nutrition based on measured caloric needs.

Nutrition Therapy
ControlDIETARY_SUPPLEMENT

Standard protocol nutrition based on calculated caloric needs.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients scheduled for conventional non-urgent cardiac surgery type coronary artery bypass graft (CABG) or aortic valve surgery

You may not qualify if:

  • urgent surgery
  • aortic arch surgery or other cardiac surgery procedures requiring sternotomy
  • off-pump cardiac surgery
  • preoperative hemodynamic instability
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25912786BACKGROUND

  • 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.

    PMID: 28365080DERIVED

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Elisabeth De Waele, MD, PhD

    UZ Brussel (Vrije Universiteit Brussel)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 15, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Publication without revealing patient ID's.