NCT02577211

Brief Summary

The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

October 10, 2015

Last Update Submit

November 7, 2015

Conditions

Critically Ill

Keywords

Critically illEnteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in the intial SOFA (Sequential Organ Failure Assessment) score at 48 hours.

    SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

    48 hours after the onset of nutrition

Secondary Outcomes (4)

  • Units of insulin require in a day

    Within the first 4 days after the onset of nutrition

  • Number of days the patient requires mechanical ventilation.

    Within the first 28 days after the onset of nutrition

  • Number of days in the intensive care unit

    Within the first 28 days after the onset of nutrition

  • Mortality to 28 days

    28 days after the onset of nutrition

Study Arms (2)

Hipocaloric enteral nutrition

EXPERIMENTAL

15 kcal per kg of body weight and 1.7 grams of protein per kg.

Dietary Supplement: Hipocaloric enteral nutrition

Normocaloric enteral nutrition

ACTIVE COMPARATOR

25 kcal per kg of body weight and 1.7 grams of protein per kg.

Dietary Supplement: Normocaloric enteral nutrition

Interventions

Hipocaloric enteral nutritionDIETARY_SUPPLEMENT

15 kcal/Kg of body weight

Also known as: low caloric delivery
Hipocaloric enteral nutrition
Normocaloric enteral nutritionDIETARY_SUPPLEMENT

25 kcal/kg of body weight

Normocaloric enteral nutrition

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Estimated fasting period of at least 96 hours
  • ICU patients

You may not qualify if:

  • Parenteral nutrition
  • Pregnancy
  • Diabetes
  • Liver failure
  • Transplantation or in transplant protocol
  • Previous nutrition support
  • Chronic Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., 000000, Colombia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saul J Rugeles, MD

    Hospital Universitario San Ignacio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 16, 2015

Study Start

December 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

CO(1)