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Screening of Nutritional Status in Cardiac Surgery

This study is currently recruiting participants.
Verified December 2012 by Meshalkin Research Institute of Pathology of Circulation
Sponsor:
Information provided by (Responsible Party):
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01366807
First received: May 31, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Nutritional Status and Predictors of Adverse Outcome in Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Mortality [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 4 weeks. ] [ Designated as safety issue: No ]
    Postoperative cardiac failure, infectious complications, clinically significant arrhythmia, bleeding

  • Intensive care unit stay [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 4 weeks. ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 4 weeks. ] [ Designated as safety issue: No ]
  • Ventilation time [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 4 weeks. ] [ Designated as safety issue: No ]
    Period between admission to ICU after the surgery and extubation


Biospecimen Retention:   Samples Without DNA

Serum, white cells


Estimated Enrollment: 3500
Study Start Date: January 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Adult patients with cardiovascular disease operated on under cardiopulmonary bypass

Exclusion Criteria:

  • Age under 18 years
  • Emergency
  • Participation in other trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366807

Contacts
Contact: Sergey M Efremov, MD, PhD 79833088415 sergefremov@mail.ru

Locations
Russian Federation
Novosibirsk Research Institute of Patholgy of Circulation Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Sergey M Efremov, MD, PhD         sergefremov@mail.ru    
Principal Investigator: Vladimir V Lomivirotov, MD, PhD            
Sub-Investigator: Sergey M Efremov, MD, PhD            
Sub-Investigator: Pavel Vedernikov, MD            
Sub-Investigator: Dmitry Nikolaev, MD            
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Vladimir V Lomivorotov, MD, PhD Novosibirsk Research Institute of Pathology of Circulation
  More Information

Publications:

Responsible Party: Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01366807     History of Changes
Other Study ID Numbers: SCR2011
Study First Received: May 31, 2011
Last Updated: December 19, 2012
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013