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

Resting Energy Needs in Brain Dead Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05070182
Acronym
SERENADE
Enrollment
66
Registered
2021-10-07
Start date
2018-06-01
Completion date
2020-12-30
Last updated
2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Death, Brain Edema, Brain Hemorrhage, Brain Injuries

Keywords

Resting energy expenditure (REE), Brain Death, Brain injuries

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.

Interventions

DIAGNOSTIC_TESTREE - Resting Energy Expenditure

REEs represent 60-70% of the needs for a sedentary person and 50% of physically active people. For the measurement of REE will be used the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA), 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. All patients in the study will be monitored with the metabolic computer. Their measurements will be recorded every day during their stay in the ICU.

DIAGNOSTIC_TESTTranscranial Doppler

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. All patients entering the study will be examined with the TCD every day during their stay in the ICU.

Sponsors

Papageorgiou General Hospital
CollaboratorOTHER
Aristotle University Of Thessaloniki
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
REE changesDay 0 (upon entry to ICU) up to 30 daysChanges in REE in patients with brain damage
MCA changesDay 0 (upon entry to ICU) up to 30 daysChanges in flow rates in Median Cerebral Artery (MCA) in patients with brain damage
REE and MCA correlationDay 0 (upon entry to ICU) up to 30 daysCorrelate the REE changes with those in flow rates in MCA

Secondary

MeasureTime frameDescription
Prognostic value of REEDay 0 (upon entry to ICU) up to 30 daysCompare the values of REE upon entry in the ICU in patients with final diagnosis as brain dead or not

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026