Enteral Nutrition After Cardiovascular Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Instituto Mexicano del Seguro Social.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universidad de Guanajuato
Information provided by (Responsible Party):
Lnca Krisein Alejandra Martinez Fuentes, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01432769
First received: September 7, 2011
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Malnutrition
Heart Disease
Dietary Supplement: dietary supplement high in energy and protein
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Enteral Nutrition in the Outcome of Patients With Cardiovascular Surgery

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • nutritional status [ Time Frame: 15 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    To measure the clinical course of patients will be reported the numbers of days of hospitalization of patients

  • Infectious complications [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    as a secondary objective of the research it will be a recorded the number of patients with infectious complications during hospitalization

  • Mortality [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    as a secondary objective of the research it will be a recorded the all cause mortality


Estimated Enrollment: 38
Study Start Date: January 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Brand name: Supportan by Fresenius Kabi
No Intervention: standardized diet
patients in the "standardized diet" will receive the dietary management established by the hospital

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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432769

Contacts
Contact: sergio e solorio meza, Doctor 7183039 soloriosergio@aol.com
Contact: krisein a martínez fuentes, Nutritionist 0444772204663 kriseina@hotmail.com

Locations
Mexico
Mexican Institute of social security: highly specialized medical unit number 1 Bajio Recruiting
Leon, Guanajuato, Mexico
Contact: sergio e solorio meza, doctor    7183039    sergiosolorio@aol.com   
Contact: krisein a martinez fuentes, nutritionist    0444772204663    kriseina@hotmail.com   
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
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
  More Information

No publications provided

Responsible Party: Lnca Krisein Alejandra Martinez Fuentes, DEGREE IN NUTRITION AND FOOD SCIENCE, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT01432769     History of Changes
Other Study ID Numbers: 2010-1001-24
Study First Received: September 7, 2011
Last Updated: September 9, 2011
Health Authority: Mexico: Ministry of Health
Mexico: Coordinación de Investigación en Salud

Keywords provided by Instituto Mexicano del Seguro Social:
enteral nutrition
malnutrition
cardiac surgery

Additional relevant MeSH terms:
Heart Diseases
Malnutrition
Nutrition Disorders
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014