Study of Postoperative Nutritional Support in Cardiac Surgery.

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Terminated; Phase 3

Conditions: Heart Diseases

Treatments: Dietary Supplement: Ensure, Abbott Nutrition; Other: standard hospital diet

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01312870

PNSICP-71421

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups, including a placebo group

postoperative nutritional supplements

Experimental group

Description:

postoperative nutritional supplements in addition to standard hospital diet

Treatment:

Dietary Supplement: Ensure, Abbott Nutrition

standard hospital diet

Placebo Comparator group

Description:

patients receiving standard hospital diet

Treatment:

Other: standard hospital diet