Enteral Nutrition After Cardiovascular Surgery

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01432769
• Other study ID #: 2010-1001-24
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2011
• Last updated: September 9, 2011
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2011
• Source: Instituto Mexicano del Seguro Social
• Contact: sergio e solorio meza, Doctor
• Phone: 7183039
• Email: soloriosergio[@]aol.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthMexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease
• Malnutrition

Intervention

Dietary Supplement:
• dietary supplement high in energy and protein
patients in the "standardized diet" will receive extra 500 kcal from the dietary supplement

Locations

Country	Name	City	State
Mexico	Mexican Institute of social security: highly specialized medical unit number 1 Bajio	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social	Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 days	No
Secondary	Days of hospitalization	To measure the clinical course of patients will be reported the numbers of days of hospitalization of patients	15 days	No
Secondary	Infectious complications	as a secondary objective of the research it will be a recorded the number of patients with infectious complications during hospitalization	15 days	No
Secondary	Mortality	as a secondary objective of the research it will be a recorded the all cause mortality	15 days	No