Enteral Nutrition After Cardiovascular Surgery

September 9, 2011 updated by: Lnca Krisein Alejandra Martinez Fuentes, Instituto Mexicano del Seguro Social

Effect of Enteral Nutrition in the Outcome of Patients With Cardiovascular Surgery

Effect of enteral nutrition in the outcome of patients has the objective to determine the effect of implementing a nutritional support protocol on the outcome of cardiovascular surgery patients, the main justification of the study its the prevalence of malnutrition over the hospitalized patients and the way this complication influence the treatment efficacy, the risk of complications over these patients, the costs, the prognosis, mortality and hospital stay.

This study will be a control clinical trial, randomized and double blind.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION: Malnutrition is a complication that occurs frequently in hospitalized patients and influencing treatment efficacy, risks of complications, costs, prognosis, mortality and hospital stay. Cardiac Cachexia is a complication that is characterized by weight loss and suggests different mechanisms to explain it: poor diet, intestinal malabsorption, impaired metabolism, loss of nutrients through the digestive tract or urinary tract, increased protein loss and decreased anabolism, increased basal metabolic rate. It is reported a reduction in mortality in cardiac patients with higher body mass index (BMI), this potential protective effect is known as the obesity paradox. In a clinical study to determine whether BMI influences the risk of mortality in acute decompensated heart failure, the authors compared the BMI of 108 927 hospitalized patients and noted that hospital mortality was decreased as BMI increased, decreasing the risk of death 10% for every 5 unit increase in BMI of patients. Moreover, the enteral nutrition within the first 48hr after surgery, helps maintain the integrity of the intestinal mucosa and reduces the secretion of catabolic hormones. A meta-analysis shows that 85% of high-risk surgical patients tolerate enteral nutrition in the early postoperative period. As a nutritional support in critically ill patients, enteral keeps physiological mechanisms, a lower incidence of complications and low cost. Nutritional support in critically ill patients has three objectives: to conserve body mass, modulate immune function and metabolic response to moderate stress.

OBJECTIVE OF THE STUDY: To determine the effect of implementing a nutritional support protocol on the outcome of cardiovascular surgery patients.

METHODOLOGY: The investigators performed a controlled clinical trial in adult patients, both genders admitted to the coronary intensive care UMAE. IMSS No.1, having undergone cardiac surgery with or without pump. There will be a nutritional screening and patients with malnutrition are included at random to group A (which will immunomodulatory individualized diet) or group B (conventional nutritional treatment). The protocol will be given nutritional support enterally during their hospital stay. The progress of nutritional status will be measured by weight, BMI, albumin, transferrin, total count of lymphocytes and total proteins in addition to the hospital stay, complications and mortality. A comparison of the effect of individualized nutritional support with a standard control group will be performed.

ANALYSIS: The results will be emptied in a database in Excel. The investigators will use statistical packages: NCSS 2007 (01/07/1919) and SPSS (15.0). Qualitative variables will be expressed as percentages, quantitative variables as mean and standard deviation if the distribution is normal. The results will be analyzed according to intention to treat. Comparison of nutritional status by various quantitative indicators will be made by paired t test or Mann Whitney according to their distribution. Categorical variables were expressed as proportions and compared using Chi Square test. All tests will be considered significant p values less than 5%.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Guanajuato
      • Leon, Guanajuato, Mexico
        • Recruiting
        • Mexican Institute of social security: highly specialized medical unit number 1 Bajio
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing cardiac surgery for revascularization, valve implant.
  • Patients with some degree of malnutrition or at risk of malnutrition according to the implementation of the Nutritional Risk Screening-2002.
  • By letter of informed consent.

Exclusion Criteria:

  • Patients with cancer diagnosis, liver disease, kidney disease.
  • Patients who decide to come out the study
  • Patients who are transferred to other hospitals
  • Patients with complications that prevent them from receiving enteral nutritional.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: individualized diet
patients will receive a diet individualized to their calorie and protein requirements besides to dietary supplementation with a polymeric formula
Dietary supplement: dietary supplement high in energy and protein
patients in the "standardized diet" will receive extra 500 kcal from the dietary supplement
Other Names:
  • Brand name: Supportan by Fresenius Kabi
No Intervention: standardized diet
patients in the "standardized diet" will receive the dietary management established by the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional status
Time Frame: 15 days

Will be monitoring anthropometric indicators of nutritional status: weight and BMI, during hospitalization and weekly basis. Will be monitoring the biochemical indicators of nutritional status, albumin, transferrin, total lymphocyte count and total protein during hospitalization and weekly basis.

Will be monitoring dietary indicators of nutritional status, daily protein intake and total calories during the hospitalization and daily newspaper.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of hospitalization
Time Frame: 15 days
To measure the clinical course of patients will be reported the numbers of days of hospitalization of patients
15 days
Infectious complications
Time Frame: 15 days
as a secondary objective of the research it will be a recorded the number of patients with infectious complications during hospitalization
15 days
Mortality
Time Frame: 15 days
as a secondary objective of the research it will be a recorded the all cause mortality
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Collaborators

Universidad de Guanajuato

Investigators

  • Study Director: sergio e solorio meza, Doctor, Instituto Mexicano del Seguro Social
  • Study Chair: guadalupe reynaga ornelas, researcher, Guanajuato's University
  • Principal Investigator: krisein a martinez fuentes, Nutritionist, Secretary of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 9, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-1001-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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