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Study of Postoperative Nutritional Support 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:
NCT01312870
First received: March 2, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .


Condition Intervention Phase
Heart Diseases
 Dietary Supplement: Ensure, Abbott Nutrition
Other: standard hospital diet
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Cardiac arrhythmia, infectious complications.

  • Total lymphocyte count [ Time Frame: before operation, 7, 14, 21 postoperative days ] [ Designated as safety issue: No ]
  • Serum albumin [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ] [ Designated as safety issue: No ]
  • Serum prealbumin [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ] [ Designated as safety issue: No ]
  • Retinol-binding protein [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: postoperative nutritional supplements
postoperative nutritional supplements in addition to standard hospital diet
 Dietary Supplement: Ensure, Abbott Nutrition
Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
Placebo Comparator: standard hospital diet
patients receiving standard hospital diet
 Other: standard hospital diet
standard hospital diet

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Absolute lymphocyte count < 1500
  • Albumin <35 g/L
  • Body mass index<21 kg/m2
  • "B" class of nutritional status according to Subjective Global Assessment

Exclusion Criteria:

  • Hepatitis B, C
  • Total circulatory arrest
  • Absence of informed consent signed
  • Chronic liver diseases
  • Gastric resection in patient's history
  • Physical limitations of normal feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312870

Contacts
Contact: Vladimir Lomivorotov, MD, PhD vvlom@mail.ru
Contact: Sergey Efremov, MD, PhD sergefremov@mail.ru

Locations
Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Recruiting
Novosibirsk, Russian Federation
State Research Institute of CIrculation Pathology Not yet recruiting
Novosibirsk, Russian Federation
Contact: Vladimir Lomivotov, MD, Prof.         vvlom@mail.ru    
Principal Investigator: Vladimir Lomivorotov, MD, PhD            
Sub-Investigator: Sergey Efremov, MD, PhD            
Sub-Investigator: Alexandr Svyatchenko            
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

No publications provided

Responsible Party: Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01312870     History of Changes
Other Study ID Numbers: PNSICP-71421
Study First Received: March 2, 2011
Last Updated: December 19, 2012
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013