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Completed

NCT Number: NCT05070182

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

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.

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Key information

Conditions

Brain Death Brain Diseases Brain Edema Brain Hemorrhage Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coma Consciousness Disorders Craniocerebral Trauma Death Hemorrhage Intracranial Hemorrhages Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Unconsciousness Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Papageorgiou General Hospital

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REE - Resting Energy Expenditure

Diagnostic Test

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.

Transcranial Doppler

Diagnostic Test

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.

Primary outcomes

  1. REE changes

    Time frame: Day 0 (upon entry to ICU) up to 30 days

    Changes in REE in patients with brain damage

  2. MCA changes

    Time frame: Day 0 (upon entry to ICU) up to 30 days

    Changes in flow rates in Median Cerebral Artery (MCA) in patients with brain damage

  3. REE and MCA correlation

    Time frame: Day 0 (upon entry to ICU) up to 30 days

    Correlate the REE changes with those in flow rates in MCA

Secondary outcomes

  1. Prognostic value of REE

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Papageorgiou General Hospital

Registry information

Official study title

Resting Energy Needs in Brain Dead Patients

Acronym: SERENADE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2021
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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