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Clinical Trials/NCT01312870
NCT01312870
Terminated
Phase 3

Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

Meshalkin Research Institute of Pathology of Circulation2 sites in 1 country21 target enrollmentMarch 2011
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ConditionsHeart Diseases

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Enrollment
21
Locations
2
Primary Endpoint
Mortality
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible Party
Principal Investigator
Principal Investigator

Efremov Sergey

Anesthesist

Meshalkin Research Institute of Pathology of Circulation

Eligibility 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

Outcomes

Primary Outcomes

Mortality

Time Frame: 1 month

Secondary Outcomes

  • Postoperative complications(1 month)
  • Total lymphocyte count(before operation, 7, 14, 21 postoperative days)
  • Serum albumin(Before operation, 7, 14, 21 postoperaitve days)
  • Serum prealbumin(Before operation, 7, 14, 21 postoperaitve days)
  • Retinol-binding protein(Before operation, 7, 14, 21 postoperaitve days)

Study Sites (2)

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