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NCT01312870 Clinical Trial

Study of Postoperative Nutritional Support in Cardiac Surgery.

Heart Diseases Clinical Trial

Official title:
Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01312870
Other study ID # PNSICP-71421
Secondary ID
Status Terminated
Phase Phase 3
First received March 2, 2011
Last updated March 23, 2015
Start date March 2011
Est. completion date March 2015

Study information
Verified date March 2015
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 21
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality 1 month No
Secondary Postoperative complications Cardiac arrhythmia, infectious complications. 1 month No
Secondary Total lymphocyte count before operation, 7, 14, 21 postoperative days No
Secondary Serum albumin Before operation, 7, 14, 21 postoperaitve days No
Secondary Serum prealbumin Before operation, 7, 14, 21 postoperaitve days No
Secondary Retinol-binding protein Before operation, 7, 14, 21 postoperaitve days No
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