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

Brain Injuries Clinical Trial

— SERENADE  

Official title:

Resting Energy Needs in Brain Dead Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05070182
• Other study ID #: 3/24-02.05.2018
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2021
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Brain Edema
• Brain Hemorrhage
• Brain Injuries
• Hemorrhage
• Intracranial Hemorrhages

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Papageorgiou General Hospital	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Papageorgiou General Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REE changes	Changes in REE in patients with brain damage	Day 0 (upon entry to ICU) up to 30 days
Primary	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
Primary	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	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