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Brain DeathSERENADENCT05070182

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

An observational study of Brain Death and Brain Injuries, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Brain Death, Brain Injuries, Brain Edema
What is being tested?
REE - Resting Energy Expenditure and Transcranial Doppler
How many people
66 participants
Where
1 siteGreece
Study dates
1 Jun 2018to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Adult patients entering the ICU
  • Age 18-90 years old
  • Clinical Diagnosis of brain damage
  • GCS <=8

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Greece1 site

  • Papageorgiou General Hospital

    Thessaloniki

Other trials in Greece

About this study

Official title: 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.

Read the 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.

Being tested
REE - Resting Energy Expenditure, Transcranial Doppler
Keywords
Resting energy expenditure (REE), Brain Death, Brain injuries
Medical subject headings
Brain Death, Brain Injuries, Brain Edema, Intracranial Hemorrhages

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REE - Resting Energy ExpenditureDiagnostic 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 DopplerDiagnostic 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.

Study groups in NCT05070182
Study groupRoleWhat they receive
Patients with brain damageICU 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
Receives: Diagnostic Test: REE - Resting Energy Expenditure; Diagnostic Test: Transcranial Doppler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. REE changes

    Changes in REE in patients with brain damage

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

  2. MCA changes

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

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

  3. REE and MCA correlation

    Correlate the REE changes with those in flow rates in MCA

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

Secondary outcomes (1)

  1. Prognostic value of REE

    Compare the values of REE upon entry in the ICU in patients with final diagnosis as brain dead or not

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2021
  2. Study start1 Jun 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05070182
Sponsor's protocol ID
3/24-02.05.2018
Acronym
SERENADE
Status last verified
Sep 2021
First submitted
17 Sep 2021
Last updated
7 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 10800264

  • 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.

    PubMed 20872036

  • 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.

    PubMed 17374800

  • 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.

    PubMed 10501754

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Death and Brain Injuries, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

REE changes (time frame: Day 0 (upon entry to ICU) up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070182, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.

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