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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Completed
CT.gov ID
NCT05070182
Collaborator
Papageorgiou General Hospital (Other)
66
1
31
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Resting Energy Needs in Brain Dead Patients
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. REE changes [Day 0 (upon entry to ICU) up to 30 days]

    Changes in REE in patients with brain damage

  2. MCA changes [Day 0 (upon entry to ICU) up to 30 days]

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

  3. REE and MCA correlation [Day 0 (upon entry to ICU) up to 30 days]

    Correlate the REE changes with those in flow rates in MCA

Secondary Outcome Measures

  1. Prognostic value of REE [Day 0 (upon entry to ICU) up to 30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Papageorgiou General Hospital Thessaloniki Greece

Sponsors and Collaborators

  • Aristotle University Of Thessaloniki
  • Papageorgiou General Hospital

Investigators

  • Principal Investigator: Chryssa Pourzitaki, MD, PhD, Faculty of Medicine, School of Health Sciences, Aristotle University of Thessaloniki

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chrysoula Pourzitaki, Principal Investigator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT05070182
Other Study ID Numbers:
  • 3/24-02.05.2018
First Posted:
Oct 7, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chrysoula Pourzitaki, Principal Investigator, Aristotle University Of Thessaloniki
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021