Status:
UNKNOWN
Calorimetry Guided Nutrition vs. Recommended Daily Intake in Weaning Chronically Ventilated Patients: Double Blind RCT.
Lead Sponsor:
Reuth Rehabilitation Hospital
Conditions:
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study, we intend to examine the effectiveness of an indirect calorimetry-guided nutrition plan, compared to the conventional, RDI-guided nutrition plan in mechanically ventilated patients, in ...
Detailed Description
Background: The number of patients in need of prolonged mechanical ventilation as means of life support is rapidly growing due to advancements in life-saving medical care for critically ill patients, ...
Eligibility Criteria
Inclusion
- Newly admitted prolonged mechanical ventilation patients on tracheostomy tube ventilation (over 21 days, a minimum of 6 hours a day);
- Over 18 years of age;
- PEEP below 8 cm H2O;
- FiO2 below 60%;
- Hemodynamically stable:
- Alert and oriented (does not apply to patients in a vegetative state);
- Blood pressure at or above 80/50 mmHg;
- Body temperature - normal around 36.6°C;
- Heart rate - 40-140 beats per minute;
- Breath - 10-20 breaths per minute;
- No active infection (clinically stable patients receiving antibiotic treatment for more than 48 hours following an acute infection may be enrolled in the trial);
Exclusion
- Ventilated patients with PEEP values exceeding 8 cmH2O, which mandates the use of FiO2 values over 60%;
- Hemodynamically unstable patients:
- Blood pressure below 80/50 mmHg;
- Over 140 beats per minute, or less than 40 beats per minute in symptomatic patients;
- Newly diagnosed fever (over 38.0°C);
- Patients receiving antibiotics for an active infection, under 48 hours.
- Blood pH values below 7.3 due to metabolic abnormality;
- Patients with irreversible advanced musculoskeletal neurodegenerative disorders.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04825717
Start Date
December 1 2019
End Date
December 31 2024
Last Update
July 11 2023
Active Locations (1)
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1
Reuth Rehabilitation Hospital
Tel Aviv, Israel