Suspended
Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.
What is being tested
Hypocaloric feeding
Other
Who is being recruted
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: September 2012
Summary
Principal SponsorWolfson Medical Center
Study ContactArie Soroksky, M.D.More contacts
Last updated: August 15, 2012Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2012
Actual date on which the first participant was enrolled.Therefore, the aim of our study is to establish the exact amount of calories to be delivered by indirect calorimetry individually for each patient. Thereafter, each patient will be randomized to the trophic group (hypocaloric feeding), or to the full energy delivery group.
Principal SponsorWolfson Medical Center
Study ContactArie Soroksky, M.D.More contacts
Last updated: August 15, 2012Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Anticipated Mechanical ventilation for at least 72 hrs
Need for enteral feeding
men and woman aged 18 or older
4 exclusion criteria prevent from participating
Abdominal surgery with inability to feed enterally
Bronchopleural fistula
FiO2 greater than 80%
Hemodynamic instability in spite the use of vassopressors
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
intervention - Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
Group II
No InterventionDaily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours.
In this group only 100% of REE will be provided.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center