TICACOS International

NCT01479673 | Unknown DMC

• 1 other identifier: 4329
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections. Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.

Conditions

Mechanical Ventilation Complication

Keywords

Enteral Nutrition; Parenteral Nutrition; Indirect Calorimetry; Intravenous Feeding

Outcome Measures

Primary Outcomes (1)

• Rate of nosocomial infections

  Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated

  After 48 to 72 hours /daily assessment: within 28 day

Secondary Outcomes (2)

• Metabolic control

  Day 1 up to day 28/or discharge

• Caloric control

  Day 1 up to day 28/or discharge

Study Arms (2)

Control group

NO INTERVENTION

Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice.

Indirect Calorimetry

EXPERIMENTAL

Study group: Indirect Calorimetry (IC) Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry measurement of Resting Energy Expenditure (REE).

Dietary Supplement: Indirect Calorimetry measurement of Resting Energy Expenditure .

Interventions

Indirect Calorimetry measurement of Resting Energy Expenditure . DIETARY_SUPPLEMENT

Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry.

Indirect Calorimetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
• Age ≥ 18 years;no upper age limit.
• Expected stay in ICU\> 3 days: \[SAPS II (18) \> ICU median or high-level of nursing care implemented or per clinical impression of attending physician\]
• Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.

You may not qualify if:

• Pregnancy.
• DNR order.
• Readmission in the ICU during the same hospitalization/transfer from other ICU.
• Admission for postoperative monitoring.
• Respiratory instability: SpO2 \<90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate \> 35/min)
• Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration).
• Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system.
• FiO2 80% or patients requiring prone position
• Chronic/acute liver failure:Child-Pugh class C
• Brain injury for various reasons with Glasgow Coma Scale below 10.
• Cardiac surgery patients.
• Patients in the hospital for more than 7 days.
• Contra indication to use enteral nutrition.
• Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial.
• Ethical issues that will influence subject eligibility.

Sponsors & Collaborators

• Rabin Medical Center: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Rabin Medical Center, Campus Beilinson

Petah Tikva, Petach Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Singer, MD, Professor

  RabinMC,Beilinson Hospital

  PRINCIPAL INVESTIGATOR

• Milana Grinev, RN,Study Coordinator

  RabinMC, Beilinson Hospital ,Petah- Tikva, Israel

  STUDY DIRECTOR

Central Study Contacts

Pierre Singer, MD,Professor

CONTACT

972-3-9376521; psinger@clalit.org.il

Milana Grinev, RN

CONTACT

972-3-9376521; milang@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pierre Singer, MD

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IL (1)