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TerminatedNCT01312870Updated Mar 24, 2015

Study of Postoperative Nutritional Support in Cardiac Surgery.

A Phase 3 interventional study of Ensure, Abbott Nutrition and standard hospital diet in Heart Diseases, sponsored by Meshalkin Research Institute of Pathology of Circulation. Terminated at 2 sites in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 3, Interventional, and Treatment

Why this study was terminated
Slow recruitment
Phase
Phase 3
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Heart Diseases

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 21 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

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Lead sponsor

Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 114 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    postoperative nutritional supplements

    postoperative nutritional supplements in addition to standard hospital diet

    Dietary Supplement: Ensure, Abbott Nutrition

  • Placebo comparator
    standard hospital diet

    patients receiving standard hospital diet

    Other: standard hospital diet

Interventions

  • Dietary supplementEnsure, Abbott Nutrition

    Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days

  • Otherstandard hospital diet

    standard hospital diet

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 1 month

Secondary outcomes

  1. Postoperative complications

    Cardiac arrhythmia, infectious complications.

    Time frame: 1 month

  2. Total lymphocyte count

    Time frame: before operation, 7, 14, 21 postoperative days

  3. Serum albumin

    Time frame: Before operation, 7, 14, 21 postoperaitve days

  4. Serum prealbumin

    Time frame: Before operation, 7, 14, 21 postoperaitve days

  5. Retinol-binding protein

    Time frame: Before operation, 7, 14, 21 postoperaitve days

07

Study locations

2 sites
  • State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
    Novosibirsk, Russian Federation
  • State Research Institute of CIrculation Pathology
    Novosibirsk, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01312870
Lead sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible party
Efremov Sergey (Anesthesist, Meshalkin Research Institute of Pathology of Circulation) — Principal investigator
First posted
Mar 11, 2011
Start date
Mar 2011
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 24, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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