Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients Guided by Indirect Calorimetry, a Prospective, Blinded, Randomized Controlled Trial.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01665664

Enrollment

200

Registered

2012-08-15

Start date

2012-09-30

Completion date

2013-10-31

Last updated

2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding

Keywords

Indirect calorimetry, hypocaloric feeding

Brief 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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
All cause mortality, ICU mortality, Hospital mortality.	1 year	All cause mortality, ICU mortality, Hospital mortality.

Secondary

Measure	Time frame	Description
ICU and Hospital LOS, Length of mechanical ventilation, rate of infections,	1 year	ICU LOS, Hospital LOS, Length of mechanical ventilation, ventilation free days, rate of infections, rate of ventilator associated pneumonia,

Countries

Israel

Contacts

Primary ContactArie Soroksky, M.D.

soroksky@gmail.com972-50-4056787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026