Clinical trial NCT03024021: Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
Official title: The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Post-Cardiorespiratory Arrest Coma
Cardiac Arrest
Keywords: therapeutic hypothermia
targeted temperature management
neurological outcome
post-cardiac arrest syndrome
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing therapeutic hypothermia after cardiac arrest in a tertiary intensive care unit

Brief summary: This study is designed to assess the effect of cerebral oxygen saturation as an early predictor of neurological outcomes in patients undergoing therapeutic hypothermia after cardiac arrest

Detailed description: Our study is planned as a prospective observational study. Patients undergoing therapeutic hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6 hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised in every 6 hours during the first day of hypothermia and than the mean values of daily cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia. Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during normothermia, day 21 and the day of discharge from ICU.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old
* Patients undergoing therapeutic hypothermia

Exclusion Criteria:

* Patients under 18 years
* Patients unsuitable for therapeutic hypothermia

Primary outcomes:
measure: Measure of cerebral oximetry
timeFrame: 8 times during the first 48 hours of hospitalization
Secondary outcomes:
measure: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score
timeFrame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
Other outcomes:
measure: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with Four score
timeFrame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
Locations:
city: Izmir
country: Turkey
facility: Tepecik Research and Training Hospital
state: Konak
Study officials:
affiliation: Tepecik Research and Training Hospital
name: Aykut Saritas
role: STUDY_DIRECTOR
affiliation: suat seren research and training hospital
name: Burcu Acar Cinleti
role: STUDY_CHAIR
affiliation: Tepecik Research and Training Hospital
name: Ciler Zincircioglu
role: STUDY_CHAIR
affiliation: Tepecik Research and Training Hospital
name: İsil Kose
role: STUDY_CHAIR
affiliation: Tepecik Research and Training Hospital
name: Ugur Uzun
role: STUDY_CHAIR
affiliation: Tepecik Research and Training Hospital
name: Nimet Senoglu
role: STUDY_CHAIR
References:
citation: Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.
citation: Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.
citation: Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.