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Study of Postoperative Nutritional Support in Cardiac Surgery.

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ClinicalTrials.gov Identifier: NCT01312870
Recruitment Status : Terminated (Slow recruitment)
First Posted : March 11, 2011
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
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.
Study Start Date : March 2011
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

  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 ]

Eligibility Criteria

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 Posted: March 11, 2011    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases