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Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

NCT ID: NCT01665664

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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Underfeeding in the critically ill patient is a common observable fact throughout intensive care units. Patients who develop caloric deficit during their stay in the ICU have been shown in previous reports to be associated with increased complications such as increased rate of infections, and nosocomial blood stream infections. Yet, other studies have shown that patients with moderate caloric deficit may be associated with better outcome than patients who receive higher levels of caloric intake.

Detailed Description

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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.

Conditions

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Enteral Feeding

Keywords

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Indirect calorimetry hypocaloric feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hypocaloric feeding group

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 Type OTHER

Hypocaloric feeding

Intervention Type OTHER

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.

Full energy feeding group

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 100% of REE will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hypocaloric feeding

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.

Intervention Type OTHER

Other Intervention Names

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trophic group

Eligibility Criteria

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Inclusion Criteria

* Anticipated Mechanical ventilation for at least 72 hrs.
* Need for enteral feeding
* men and woman aged 18 or older.

Exclusion Criteria

* Abdominal surgery with inability to feed enterally.
* FiO2 greater than 80%
* Bronchopleural fistula
* Hemodynamic instability in spite the use of vassopressors.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Soroksky Arie

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arie Soroksky, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson MC

Locations

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Wolfson MC

Holon, , Israel

Site Status

Countries

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Israel

Central Contacts

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Arie Soroksky, M.D.

Role: CONTACT

Phone: 972-50-4056787

Email: [email protected]

Facility Contacts

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Arie Soroksky, MD

Role: primary

Other Identifiers

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0014-12-WOMC

Identifier Type: -

Identifier Source: org_study_id