Screening of Nutritional Status in Cardiac Surgery

Cardiovascular Diseases Clinical Trial

Official title:

Screening of Nutritional Status and Predictors of Adverse Outcome in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366807
• Other study ID #: SCR2011
• Status: Completed
• Start date: January 2011
• Est. completion date: October 2013

Study information

• Verified date: January 2020
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1210
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with cardiovascular disease operated on under cardiopulmonary bypass

Exclusion Criteria:

• Age under 18 years

• Emergency

• Participation in other trial.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Patholgy of Circulation	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Secondary	Complications	Postoperative cardiac failure, infectious complications, clinically significant arrhythmia, bleeding	Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Secondary	Intensive care unit stay		Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Secondary	Hospital stay		Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Secondary	Ventilation time	Period between admission to ICU after the surgery and extubation	Participants will be followed for the duration of hospital stay, an average of 4 weeks.