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Study of Postoperative Nutritional Support 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:
NCT01312870
First received: March 2, 2011
Last updated: October 30, 2013
Last verified: October 2013
  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:


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
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: NCT01312870

Locations
Russian Federation
State Research Institute of CIrculation Pathology
Novosibirsk, Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, Russian Federation
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: October 30, 2013
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014