NCT01432769

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

1.1 years

First QC Date

September 7, 2011

Last Update Submit

September 9, 2011

Conditions

MalnutritionHeart Disease

Keywords

enteral nutritionmalnutritioncardiac surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Days of hospitalization

    15 days

  • Infectious complications

    15 days

  • Mortality

    15 days

Study Arms (2)

individualized diet

ACTIVE COMPARATOR

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

standardized diet

NO INTERVENTION

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

Interventions

dietary supplement high in energy and proteinDIETARY_SUPPLEMENT

patients in the "standardized diet" will receive extra 500 kcal from the dietary supplement

Also known as: Brand name: Supportan by Fresenius Kabi
individualized diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

León, Guanajuato, Mexico

RECRUITING

MeSH Terms

Conditions

MalnutritionHeart Diseases

Interventions

Proteins

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

  • sergio e solorio meza, Doctor

    Instituto Mexicano del Seguro Social

    STUDY DIRECTOR

  • guadalupe reynaga ornelas, researcher

    Guanajuato's University

    STUDY CHAIR

  • krisein a martinez fuentes, Nutritionist

    Secretary of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

sergio e solorio meza, Doctor

CONTACT

7183039soloriosergio@aol.com

krisein a martínez fuentes, Nutritionist

CONTACT

0444772204663kriseina@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DEGREE IN NUTRITION AND FOOD SCIENCE

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 13, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

March 1, 2012

Last Updated

September 13, 2011

Record last verified: 2011-09

Locations

ME(1)