NCT01312870

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

March 2, 2011

Last Update Submit

March 23, 2015

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 month

Secondary Outcomes (5)

  • Postoperative complications

    1 month

  • Total lymphocyte count

    before operation, 7, 14, 21 postoperative days

  • Serum albumin

    Before operation, 7, 14, 21 postoperaitve days

  • Serum prealbumin

    Before operation, 7, 14, 21 postoperaitve days

  • Retinol-binding protein

    Before operation, 7, 14, 21 postoperaitve days

Study Arms (2)

postoperative nutritional supplements

EXPERIMENTAL

postoperative nutritional supplements in addition to standard hospital diet

Dietary Supplement: Ensure, Abbott Nutrition

standard hospital diet

PLACEBO COMPARATOR

patients receiving standard hospital diet

Other: standard hospital diet

Interventions

Ensure, Abbott NutritionDIETARY_SUPPLEMENT

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

postoperative nutritional supplements
standard hospital dietOTHER

standard hospital diet

standard hospital diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absolute lymphocyte count \< 1500
  • Albumin \<35 g/L
  • Body mass index\<21 kg/m2
  • "B" class of nutritional status according to Subjective Global Assessment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation

Novosibirsk, Russia

Location

State Research Institute of CIrculation Pathology

Novosibirsk, Russia

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesist

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 11, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

RU(2)