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

March 2, 2011
October 30, 2013
March 2011
February 2014   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01312870 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Postoperative Nutritional Support in Cardiac Surgery.
Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Diseases
  • Dietary Supplement: Ensure, Abbott Nutrition
    Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
  • Other: standard hospital diet
    standard hospital diet
  • Experimental: postoperative nutritional supplements
    postoperative nutritional supplements in addition to standard hospital diet
    Intervention: Dietary Supplement: Ensure, Abbott Nutrition
  • Placebo Comparator: standard hospital diet
    patients receiving standard hospital diet
    Intervention: Other: standard hospital diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
200
Not Provided
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01312870
PNSICP-71421
Yes
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Not Provided
Meshalkin Research Institute of Pathology of Circulation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP