Energy Expenditure Estimation in Cardiac Surgery

• Sponsor: Meshalkin Research Institute of Pathology of Circulation (Other)
• Overall Status: Completed
• CT.gov ID: NCT02463123
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Actual Duration (Months): 25
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief Summary

Estimation of energy requirements is essential for adequate nutritional support in ICU. Indirect calorimetry being the golden standard of resting energy expenditure estimation is not available in most intensive care units. Different predictive equations have been developed, but not evaluated in cardiac population and have low accuracy in compare to the indirect calorimetry. The aim of present study is to develop cardio-specific equation for resting energy expenditure estimation.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Surgical Procedures; Intensive Care	Device: Indirect calorimetry

Study Design

• Study Type: Observational
• Actual Enrollment: 240 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2017

Outcome Measures

Primary Outcome Measures

1. Resting energy expenditure measured in kcal/day using indirect calorimetry [participants will be followed for the duration intensive care unit stay, an expected average 2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient of cardiothoracic ICU

Exclusion Criteria:

• Shock

• patients on ECMO

• Hypoxemia <60 mmHg

• Active bleeding

• Ventilation with FiO2 >0.6

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	State Research Institute of Circulation Pathology	Novosibirsk		Russian Federation

Sponsors and Collaborators

• Meshalkin Research Institute of Pathology of Circulation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Efremov SM, Talaban VO, Ponomarev DN, Vedernikov PE, Chechenin MG, Artemieva VV, Lomivorotov VV. Development and Validation of a New Cardio-Specific Resting Energy Expenditure Equation for Adults. JPEN J Parenter Enteral Nutr. 2018 May;42(4):702-708. doi: 10.1177/0148607117711648. Epub 2017 Dec 19.

• Responsible Party: Efremov Sergey, anestesiologist, Meshalkin Research Institute of Pathology of Circulation
• ClinicalTrials.gov Identifier: NCT02463123
• Other Study ID Numbers: 01.2015
• First Posted: Jun 4, 2015
• Last Update Posted: Aug 30, 2017
• Last Verified: Mar 1, 2017

Study Results

No Results Posted as of Aug 30, 2017