NCT01366807

Brief Summary

Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of such criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ) in cardiac surgery is controversial and insufficiently studied. Furthermore, there is some known predictors of poor outcome, which closely related to nutritional status (C-reactive protein, total lymphocyte count). The aim of this study is assessment of several nutritional screening scales, objective nutritional criteria and predictors for the purpose of detection of most informative one or its combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

May 31, 2011

Last Update Submit

January 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Participants will be followed for the duration of hospital stay, an average of 4 weeks.

Secondary Outcomes (4)

  • Complications

    Participants will be followed for the duration of hospital stay, an average of 4 weeks.

  • Intensive care unit stay

    Participants will be followed for the duration of hospital stay, an average of 4 weeks.

  • Hospital stay

    Participants will be followed for the duration of hospital stay, an average of 4 weeks.

  • Ventilation time

    Participants will be followed for the duration of hospital stay, an average of 4 weeks.

Eligibility Criteria

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

Patients, who live in Russia, mostly in Siberia whom scheduled to cardiac surgery in one institution.

You may qualify if:

  • Adult patients with cardiovascular disease operated on under cardiopulmonary bypass

You may not qualify if:

  • Age under 18 years
  • Emergency
  • Participation in other trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novosibirsk Research Institute of Patholgy of Circulation

Novosibirsk, 630055, Russia

Location

Related Publications (2)

  • Lomivorotov VV, Efremov SM, Boboshko VA, Leyderman IN, Lomivorotov VN, Cheung AT, Karaskov AM. Preoperative total lymphocyte count in peripheral blood as a predictor of poor outcome in adult cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):975-80. doi: 10.1053/j.jvca.2010.12.006. Epub 2011 Feb 26.

    PMID: 21354824BACKGROUND
  • Lomivorotov VV, Efremov SM, Boboshko VA, Nikolaev DA, Vedernikov PE, Lomivorotov VN, Karaskov AM. Evaluation of nutritional screening tools for patients scheduled for cardiac surgery. Nutrition. 2013 Feb;29(2):436-42. doi: 10.1016/j.nut.2012.08.006. Epub 2012 Nov 27.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, white cells

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Vladimir V Lomivorotov, MD, PhD

    Novosibirsk Research Institute of Pathology of Circulation

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 6, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations