Screening of Nutritional Status in Cardiac Surgery

This study has suspended participant recruitment.
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: October 30, 2013
Last verified: October 2013
  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:


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: August 2015
Estimated Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366807

Locations
Russian Federation
Novosibirsk Research Institute of Patholgy of Circulation
Novosibirsk, Russian Federation, 630055
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