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Enteral Nutrition After Cardiovascular Surgery

Primary Purpose

Malnutrition, Heart Disease

Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
dietary supplement high in energy and protein
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring enteral nutrition, malnutrition, cardiac surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mexican Institute of social security: highly specialized medical unit number 1 BajioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

individualized diet

standardized diet

Arm Description

patients will receive a diet individualized to their calorie and protein requirements besides to dietary supplementation with a polymeric formula

patients in the "standardized diet" will receive the dietary management established by the hospital

Outcomes

Primary Outcome Measures

nutritional status
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2011
Last Updated
September 9, 2011
Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT01432769
Brief Title
Enteral Nutrition After Cardiovascular Surgery
Official Title
Effect of Enteral Nutrition in the Outcome of Patients With Cardiovascular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Universidad de Guanajuato

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Heart Disease
Keywords
enteral nutrition, malnutrition, cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
individualized diet
Arm Type
Active Comparator
Arm Description
patients will receive a diet individualized to their calorie and protein requirements besides to dietary supplementation with a polymeric formula
Arm Title
standardized diet
Arm Type
No Intervention
Arm Description
patients in the "standardized diet" will receive the dietary management established by the hospital
Intervention Type
Dietary Supplement
Intervention Name(s)
dietary supplement high in energy and protein
Other Intervention Name(s)
Brand name: Supportan by Fresenius Kabi
Intervention Description
patients in the "standardized diet" will receive extra 500 kcal from the dietary supplement
Primary Outcome Measure Information:
Title
nutritional status
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Days of hospitalization
Description
To measure the clinical course of patients will be reported the numbers of days of hospitalization of patients
Time Frame
15 days
Title
Infectious complications
Description
as a secondary objective of the research it will be a recorded the number of patients with infectious complications during hospitalization
Time Frame
15 days
Title
Mortality
Description
as a secondary objective of the research it will be a recorded the all cause mortality
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sergio e solorio meza, Doctor
Phone
7183039
Email
soloriosergio@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
krisein a martínez fuentes, Nutritionist
Phone
0444772204663
Email
kriseina@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sergio e solorio meza, Doctor
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
guadalupe reynaga ornelas, researcher
Organizational Affiliation
Guanajuato's University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
krisein a martinez fuentes, Nutritionist
Organizational Affiliation
Secretary of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mexican Institute of social security: highly specialized medical unit number 1 Bajio
City
Leon
State/Province
Guanajuato
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sergio e solorio meza, doctor
Phone
7183039
Email
sergiosolorio@aol.com
First Name & Middle Initial & Last Name & Degree
krisein a martinez fuentes, nutritionist
Phone
0444772204663
Email
kriseina@hotmail.com

12. IPD Sharing Statement

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Enteral Nutrition After Cardiovascular Surgery

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