Resting Energy Needs in Brain Dead Patients (reSting EneRgy nEeds iN brAin DEad Patients)
SERENADE
1 other identifier
observational
66
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
September 17, 2021
CompletedFirst Posted
Study publicly available on registry
October 7, 2021
CompletedOctober 7, 2021
September 1, 2021
2.1 years
September 17, 2021
September 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Prognostic value of REE
Day 0 (upon entry to ICU) up to 30 days
Study Arms (1)
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
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- Adult patients entering the ICU
- Age 18-90 years old
- Clinical Diagnosis of brain damage
- GCS \<=8
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Papageorgiou General Hospital
Thessaloniki, Greece
Related 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. doi: 10.1111/jon2000102101.
PMID: 10800264BACKGROUNDMarinoni 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.
PMID: 20872036BACKGROUNDZijlstra 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.
PMID: 17374800BACKGROUNDBitzani 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.
PMID: 10501754BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chryssa Pourzitaki, MD, PhD
Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2021
First Posted
October 7, 2021
Study Start
June 1, 2018
Primary Completion
June 30, 2020
Study Completion
December 30, 2020
Last Updated
October 7, 2021
Record last verified: 2021-09