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Study of Postoperative Nutritional Support in Cardiac Surgery.

This study has been terminated.
(Slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312870
First Posted: March 11, 2011
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
  Purpose
The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .

Condition Intervention Phase
Heart Diseases Dietary Supplement: Ensure, Abbott Nutrition Other: standard hospital diet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

Resource links provided by NLM:


Further study details as provided by Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • Mortality [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Postoperative complications [ Time Frame: 1 month ]
    Cardiac arrhythmia, infectious complications.

  • Total lymphocyte count [ Time Frame: before operation, 7, 14, 21 postoperative days ]
  • Serum albumin [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ]
  • Serum prealbumin [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ]
  • Retinol-binding protein [ Time Frame: Before operation, 7, 14, 21 postoperaitve days ]

Enrollment: 21
Study Start Date: March 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: postoperative nutritional supplements
postoperative nutritional supplements in addition to standard hospital diet
Dietary Supplement: Ensure, Abbott Nutrition
Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
Placebo Comparator: standard hospital diet
patients receiving standard hospital diet
Other: standard hospital diet
standard hospital diet

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312870


Locations
Russian Federation
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Novosibirsk, Russian Federation
State Research Institute of CIrculation Pathology
Novosibirsk, Russian Federation
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
  More Information

Additional Information:
Responsible Party: Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01312870     History of Changes
Other Study ID Numbers: PNSICP-71421
First Submitted: March 2, 2011
First Posted: March 11, 2011
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases