Clinical trial NCT05070182: Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)
Official title: Resting Energy Needs in Brain Dead Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Brain Injuries
Brain Edema
Brain Hemorrhage
Keywords: Resting energy expenditure (REE)
Brain Death
Brain injuries
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Papageorgiou General Hospital
First posted: 2021-10-07
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients, aged 18-90 years old, entering the ICU, having a GCS \<=8 before any intervention, having signs of intracranial damage after a traumatic brain injury or a cardiac arrest succesfull rescucitation or a brain hemorrhage due to aneurysm.

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.

Eligibility criteria: 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

Primary outcomes:
measure: REE changes
timeFrame: Day 0 (upon entry to ICU) up to 30 days
measure: MCA changes
timeFrame: Day 0 (upon entry to ICU) up to 30 days
measure: REE and MCA correlation
timeFrame: Day 0 (upon entry to ICU) up to 30 days
Secondary outcomes:
measure: Prognostic value of REE
timeFrame: Day 0 (upon entry to ICU) up to 30 days
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
affiliation: Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki
name: Chryssa Pourzitaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Babikian VL, Feldmann E, Wechsler LR, Newell DW, Gomez CR, Bogdahn U, Caplan LR, Spencer MP, Tegeler C, Ringelstein EB, Alexandrov AV. Transcranial Doppler ultrasonography: year 2000 update. J Neuroimaging. 2000 Apr;10(2):101-15. doi: 10.1111/jon2000102101.
citation: Marinoni M, Alari F, Mastronardi V, Peris A, Innocenti P. The relevance of early TCD monitoring in the intensive care units for the confirming of brain death diagnosis. Neurol Sci. 2011 Feb;32(1):73-7. doi: 10.1007/s10072-010-0407-1. Epub 2010 Sep 25.
citation: Zijlstra N, ten Dam SM, Hulshof PJ, Ram C, Hiemstra G, de Roos NM. 24-hour indirect calorimetry in mechanically ventilated critically ill patients. Nutr Clin Pract. 2007 Apr;22(2):250-5. doi: 10.1177/0115426507022002250.
citation: Bitzani M, Matamis D, Nalbandi V, Vakalos A, Karasakalides A, Riggos D. Resting energy expenditure in brain death. Intensive Care Med. 1999 Sep;25(9):970-6. doi: 10.1007/s001340050991.