Calorimetry Guided Nutrition vs. Recommended Daily Intake in Weaning Chronically Ventilated Patients: Double Blind RCT.

NCT04825717 | Unknown DMC

• 1 other identifier: 0014-18-RRH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 terms of success rates of prolonged ventilation weaning, and shorter weaning time period. Hypotheses: The rates of chronically ventilated patients weaned off invasive ventilation will increase by 15% in the intervention group, and the average weaning period in this group will be reduced by 10 ± 4 days. Methods: A randomized controlled intervention trial that will include 200 chronically ventilated patients, admitted to the "Reuth" Rehabilitation Hospital, who meet the criteria for weaning from prolonged mechanical ventilation. Patients in the intervention group (n=100) will undergo precise calorimetric measurements using indirect calorimetry and will be administered with a nutrition plan in accordance with these measurements. Nutrition plans of patients in the control group (n=100) will be calculated and administered according to current RDI conventions (up to 24 Kcal/kg/day). In order to assure blinding, patients in the control group will undergo the same calorimetric measurements using indirect calorimetry, however, these results will not be used in any way to determine or influence the nutritional plan.

Conditions

Mechanical Ventilation

Keywords

Weaning; Mechanical Ventilation; Nutrition

Outcome Measures

Primary Outcomes (2)

• Successful weaning

  Rate of successful weaning, i.e. a number of patients successfully weaned from prolonged mechanical ventilation, out of those who underwent weaning attempts.

  Within 8 weeks

• Time to successful weaning

  Time period in days from randomization to one of the studies groups and until successful weaning or 5 failed consecutive weaning attempts.

  Within 8 weeks

Secondary Outcomes (2)

• Discharge destination following successful weaning

  Within 8 weeks

• Three months survival rates post-weaning

  3 months

Other Outcomes (1)

• Twelve months survival rates post-weaning

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements

Other: Nutrition and fluid plans prepared using calorimetry-based measurements.

Control group

NO INTERVENTION

Nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula.

Interventions

Nutrition and fluid plans prepared using calorimetry-based measurements. OTHER

Nutrition and fluid plans prepared using calorimetry-based measurements.

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reuth Rehabilitation Hospital: lead

Study Sites (1)

Reuth Rehabilitation Hospital

Tel Aviv, Israel

Location

Related Publications (1)

• Fradkin M, Elyashiv M, Brik M, Kait MG, Albukrek D, Singer P, Dankner R. The efficacy of calorimetry-based nutritional support versus recommended dietary intake-based nutritional support in the successful weaning of chronically ventilated patients: A study protocol for a double blind randomized controlled trial. Clin Nutr ESPEN. 2023 Apr;54:94-97. doi: 10.1016/j.clnesp.2023.01.003. Epub 2023 Jan 13.

  PMID: 36963903 DERIVED

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patients and the treating physicians and nurses will be blind to patient's nutritional plan (Intervention VS Control group)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled double-blinded clinical trial. Intervention group: patients in this group will be administered nutrition and fluid plans prepared by the department dietitian using calorimetry-based measurements. Control group: The nutrition plans of patients in this group will be calculated by the department dietitian using the standard, currently accepted RDI (recommended dietary intake) formula. Nutrition will be administered according to these calculations. All patients included in this trial will receive a multivitamin supplement to prevent possible vitamin deficiencies.

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: April 1, 2021
• Study Start: December 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: December 31, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

IL (1)