NCT02463123

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

May 29, 2015

Last Update Submit

August 29, 2017

Conditions

Cardiovascular Surgical ProceduresIntensive Care

Outcome Measures

Primary Outcomes (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

Interventions

Indirect calorimetryDEVICE

Resting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after cardiothoracic interventions using cardiopulmonary bypass

You may qualify if:

  • Patient of cardiothoracic ICU

You may not qualify if:

  • Shock
  • patients on ECMO
  • Hypoxemia \<60 mmHg
  • Active bleeding
  • Ventilation with FiO2 \>0.6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, Russia

Location

Related 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. 2018 May;42(4):702-708. doi: 10.1177/0148607117711648. Epub 2017 Dec 19.

    PMID: 28575581BACKGROUND

MeSH Terms

Interventions

Calorimetry, Indirect

Intervention Hierarchy (Ancestors)

CalorimetryChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anestesiologist

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 4, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

August 30, 2017

Record last verified: 2017-03

Locations

RU(1)