Clinical trial NCT01432769: Enteral Nutrition After Cardiovascular Surgery
Official title: Effect of Enteral Nutrition in the Outcome of Patients With Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malnutrition
Heart Disease
Keywords: enteral nutrition
malnutrition
cardiac surgery
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
Collaborators: name: Universidad de Guanajuato
First posted: 2011-09-13
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: nutritional status
timeFrame: 15 days
Secondary outcomes:
measure: Days of hospitalization
timeFrame: 15 days
measure: Infectious complications
timeFrame: 15 days
measure: Mortality
timeFrame: 15 days
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Mexican Institute of social security: highly specialized medical unit number 1 Bajio
state: Guanajuato
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: sergio e solorio meza, Doctor
role: STUDY_DIRECTOR
affiliation: Guanajuato's University
name: guadalupe reynaga ornelas, researcher
role: STUDY_CHAIR
affiliation: Secretary of Health
name: krisein a martinez fuentes, Nutritionist
role: PRINCIPAL_INVESTIGATOR
References: