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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Brain Death; Brain Edema; Brain Hemorrhage
• Intervention / Treatment: Diagnostic test: REE - Resting Energy Expenditure; Diagnostic test: Transcranial Doppler

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Papageorgiou General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with brain damage; 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

Diagnostic test: REE - 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 test: Transcranial 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Papageorgiou General Hospital
• Investigators: Principal Investigator: Chryssa Pourzitaki, MD, PhD, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 7, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Brain injuries; Brain Death; Resting energy expenditure (REE)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Death; Unconsciousness; Consciousness Disorders; Coma; Brain Injuries; Hemorrhage; Intracranial Hemorrhages; Brain Death; Brain Edema
• Other Study ID Numbers: 3/24-02.05.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No