ClinicalTrials.Veeva

Menu

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

A

Aristotle University Of Thessaloniki

Status

Completed

Conditions

Brain Injuries
Brain Edema
Brain Death
Brain Hemorrhage

Treatments

Diagnostic Test: REE - Resting Energy Expenditure
Diagnostic Test: Transcranial Doppler

Study type

Observational

Funder types

Other

Identifiers

NCT05070182
3/24-02.05.2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

66 participants in 1 patient group

Patients with brain damage
Description:
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
Treatment:
Diagnostic Test: REE - Resting Energy Expenditure
Diagnostic Test: Transcranial Doppler

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems