Back to resultsStudy of Postoperative Nutritional Support in Cardiac Surgery.
Primary Purpose
Heart Diseases
Status
Terminated
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Ensure, Abbott Nutrition
standard hospital diet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Diseases
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
Sites / Locations
- State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
- State Research Institute of CIrculation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
postoperative nutritional supplements
standard hospital diet
Arm Description
postoperative nutritional supplements in addition to standard hospital diet
patients receiving standard hospital diet
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Postoperative complications
Cardiac arrhythmia, infectious complications.
Total lymphocyte count
Serum albumin
Serum prealbumin
Retinol-binding protein
Full Information
NCT ID
NCT01312870
First Posted
March 2, 2011
Last Updated
March 23, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01312870
Brief Title
Study of Postoperative Nutritional Support in Cardiac Surgery.
Official Title
Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postoperative nutritional supplements
Arm Type
Experimental
Arm Description
postoperative nutritional supplements in addition to standard hospital diet
Arm Title
standard hospital diet
Arm Type
Placebo Comparator
Arm Description
patients receiving standard hospital diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure, Abbott Nutrition
Intervention Description
Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
Intervention Type
Other
Intervention Name(s)
standard hospital diet
Intervention Description
standard hospital diet
Primary Outcome Measure Information:
Title
Mortality
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Cardiac arrhythmia, infectious complications.
Time Frame
1 month
Title
Total lymphocyte count
Time Frame
before operation, 7, 14, 21 postoperative days
Title
Serum albumin
Time Frame
Before operation, 7, 14, 21 postoperaitve days
Title
Serum prealbumin
Time Frame
Before operation, 7, 14, 21 postoperaitve days
Title
Retinol-binding protein
Time Frame
Before operation, 7, 14, 21 postoperaitve days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
City
Novosibirsk
Country
Russian Federation
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Study of Postoperative Nutritional Support in Cardiac Surgery.
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