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

NCT ID: NCT05070182

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Brain Death Brain Injuries Brain Edema Brain Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

REE - Resting Energy Expenditure

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papageorgiou General Hospital

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Chrysoula Pourzitaki

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chryssa Pourzitaki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki

Locations

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Papageorgiou General Hospital

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 10800264 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20872036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17374800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10501754 (View on PubMed)

Other Identifiers

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3/24-02.05.2018

Identifier Type: -

Identifier Source: org_study_id

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