Effect of Enteral Nutrition Enriched in Protein and Based on Indirect Calorimetry Measurement in Chronically Critically Ill Patients

Summary

This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study intended to establish 1) the optimal method of determining calorie requirements and 2) the optimal amount of protein supply in chronically ventilated patients.

Conditions

• Critically Ill

Interventions

OTHER

Caloric Support (Group 1)

Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).

OTHER

Caloric Support (Group 2)

For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)

DIETARY_SUPPLEMENT

Protein dose of 1.1 to 1.5 grams per kilogram weight.

Patients in the first group(Group 1A) will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.

DIETARY_SUPPLEMENT

Protein at 1.1 grams per kilogram weight.

Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.

DIETARY_SUPPLEMENT

protein at a dose of 1.5 grams per kilogram weight.

Patients in the third group (Group 3A) will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.

Sponsors & Collaborators

• Beit Rivka Hospital

  collaborator UNKNOWN

• Rabin Medical Center

  lead OTHER

Principal Investigators

• Gregory Papirov, MD · Beit- Rivka Hospital, Petah-Tikva, Israel

• Pierre Singer, MD, Professor · ICU, Rabin Medical Center,Petah- Tikva, Israel

• Ludmila Zaidenberg, MD · Beit Rivka hospital, Petah- Tikva, Israel

• Milana Grinev, RN,Study Coordinator · ICU, Rabin Medical Center,Petah- Tikva, Israel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2012-09-30

Completion

2012-11-30