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NCT02463123 Clinical Trial

Energy Expenditure Estimation in Cardiac Surgery

Intensive Care Clinical Trial

Official title:
Resting Energy Expenditure in Cardiac Patients Operated Under Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02463123
Other study ID # 01.2015
Secondary ID
Status Completed
Phase N/A
First received May 29, 2015
Last updated August 29, 2017
Start date May 2015
Est. completion date June 2017

Study information
Verified date March 2017
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date June 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient of cardiothoracic ICU

Exclusion Criteria:

- Shock

- patients on ECMO

- Hypoxemia <60 mmHg

- Active bleeding

- Ventilation with FiO2 >0.6

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Indirect calorimetry
Resting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA).

Locations
Country Name City State
Russian Federation State Research Institute of Circulation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. 2017 Jun 1:148607117711648. doi: 10.1177/0148607117711648. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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