Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)

Completed

• Conditions: Brain Edema; Brain Death; Brain Injuries; Brain Hemorrhage
• Interventions: Diagnostic Test: REE - Resting Energy Expenditure; Diagnostic Test: Transcranial Doppler

• Registration Number: NCT05070182
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

The study will examine the resting energy need (REE) in patients suffering from brain damage. For the measurement of REE will be used a metabolic computer (which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.

Detailed Description

This is a retrospective observational study concerning patients suffering from brain damage.

All the patients suffering from brain damage are monitored in order to examine their resting energy needs (REE). For the measurement of REE the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA) is used.

The main purpose of this study is to reveal the (REE) changing in patients with brain death semiology and examine if the REE changes could be related to the outcome of a patient with intracranial pathology. Moreover the study will examine if the changes in REE measurement are related to changes in flow velocities in the midbrain.

Any measurement shall be preceded by calibration of the metabolic computer pneumotachograph with a 3-liter syringe with an acceptable error of less than 9 ml / lit. The metabolic unit is calibrated for VO2 measurements with two calibration cylinders containing 21% and 12% O2 and for VCO2 measurements with calibration gases containing 5% and 0% CO2 respectively.

The measurement of flow velocities in the middle cerebral artery will be done with the transcranial Doppler using a low frequency (2 MHz) ultrasound head After their final diagnosis (brain death or not) the patients' characteristics will be compared according to the categorization as "brain dead" or not.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30
• Status Verified: 2021-09
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-26
• Last Update Submitted: 2021-09-26
• Study First Posted: 2021-10-07
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Adult patients entering the ICU
• Age 18-90 years old
• Clinical Diagnosis of brain damage
• GCS <=8

Exclusion Criteria

• Patients <18 years old and >90 years old,
• Past history CNS disease (alzheimer's disease, multiple sclerosis, brain tumor, aneurysm) in the last 3 years
• Past history of cachexia due to cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with brain damage	Transcranial Doppler	ICU patients with brain damage (due to cardiac arrest, intracranial hemorrhage or traumatic brain injury). and GCS upon entry \<=8. All patients will be examined with a transcranial doppler (TCD) and a metabolic computer (for the measurements of REE) After the final diagnosis the patients' characteristics will be compared according to if they were brain dead or not
Patients with brain damage	REE - Resting Energy Expenditure	ICU patients with brain damage (due to cardiac arrest, intracranial hemorrhage or traumatic brain injury). and GCS upon entry \<=8. All patients will be examined with a transcranial doppler (TCD) and a metabolic computer (for the measurements of REE) After the final diagnosis the patients' characteristics will be compared according to if they were brain dead or not

Primary Outcome Measures

Name	Time	Method
REE changes	Day 0 (upon entry to ICU) up to 30 days	Changes in REE in patients with brain damage
REE and MCA correlation	Day 0 (upon entry to ICU) up to 30 days	Correlate the REE changes with those in flow rates in MCA
MCA changes	Day 0 (upon entry to ICU) up to 30 days	Changes in flow rates in Median Cerebral Artery (MCA) in patients with brain damage

Secondary Outcome Measures

Name	Time	Method
Prognostic value of REE	Day 0 (upon entry to ICU) up to 30 days	Compare the values of REE upon entry in the ICU in patients with final diagnosis as brain dead or not

Trial Locations

Locations (1)

Papageorgiou General Hospital; 🇬🇷 Thessaloniki, Greece