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Status unknownNCT01665664Updated Aug 15, 2012

Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

An interventional study of Hypocaloric feeding in Enteral Feeding, sponsored by Wolfson Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-15.

Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Enteral Feeding

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Keywords

  • Indirect calorimetry
  • hypocaloric feeding
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Wolfson Medical Center is the lead sponsor of 113 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Abdominal surgery with inability to feed enterally.
  • FiO2 greater than 80%
  • Bronchopleural fistula
  • Hemodynamic instability in spite the use of vassopressors.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Other
    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.

    Other: Hypocaloric feeding

  • No intervention
    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.

Interventions

  • OtherHypocaloric 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.

    Also known as: trophic group

06

What researchers measure

Primary outcomes

  1. All cause mortality, ICU mortality, Hospital mortality.

    All cause mortality, ICU mortality, Hospital mortality.

    Time frame: 1 year

Secondary outcomes

  1. ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,

    ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,

    Time frame: 1 year

07

Study locations

1 site
  • Wolfson MC
    Holon, 58100, Israel
    • Arie Soroksky, MD · Contact · soroksky@gmail.com · 972-50-4056787
    • Arie Soroksky, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665664
Lead sponsor
Wolfson Medical Center
Responsible party
Soroksky Arie (M.D., Wolfson Medical Center) — Principal investigator
First posted
Aug 15, 2012
Start date
Sep 2012
Primary completion
Sep 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Aug 15, 2012

Study contacts

Arie Soroksky, M.D.
Contact
soroksky@gmail.com
972-50-4056787
Arie Soroksky, MD
principal investigator · Wolfson MC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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