Hypocaloric vs. Full Energy Enteral Feeding in Critically Ill Patients

Enteral Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01665664
• Other study ID #: 0014-12-WOMC
• Status: Not yet recruiting
• Phase: N/A
• First received: August 13, 2012
• Last updated: August 14, 2012
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2012
• Source: Wolfson Medical Center
• Contact: Arie Soroksky, M.D.
• Phone: 972-50-4056787
• Email: soroksky[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Enteral Feeding

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Israel	Wolfson MC	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality, ICU mortality, Hospital mortality.	All cause mortality, ICU mortality, Hospital mortality.	1 year	Yes
Secondary	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,	1 year	Yes