Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest (DOTAC)

Doppler Sonography of Cerebral Blood Flow for Early Prognostication After Out-of-hospital Cardiac Arrest: the DOTAC Study

Objective: To assess neurologic prognostication by early Transcranial Doppler Sonography (TCD) in comatose survivors after cardiac arrest.

Design: Prospective study between May 2016 and November 2017 in a medical intensive care unit and cardiac intensive care unit in a university hospital.

Patients: all comatose patients older than 18 years successfully resuscitated from an out-of-hospital cardiac arrest (OHCA). Patients for whom OHCA is associated with traumatic brain injury, no window for TCD measurements, or dead before neurological prognostication are excluded.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest

Detailed Description

The investigators measure the pulsatility index (PI) and diastolic flow velocity (DFV) of the right and left middle cerebral artery during the first 12 h after return of spontaneous circulation (ROSC). The highest value of DFV and the lowest of PI will use for the statistical analysis. Cerebral Performance Category evaluate neurologic outcome at hospital discharge.

Data provided by early TCD after ROSC are associated with neurological outcome. The use of these data could lead to the development of therapeutics improving cerebral perfusion in patient resuscitated from an OHCA.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• France
  • Rennes, France
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients resuscitated from out-of-hospital cardiac arrest

Description

Inclusion Criteria:

• older 18 years
• out-of-hospital cardiac arrest with recovery of spontaneous cardiac activity

Exclusion Criteria:

• transcranial doppler not done or not interpretable
• associated cranial trauma
• died without neurological assessment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the relation between TCD measurements and neurologic outcome at hospital discharge	Good score = CPC 1-2 and bad score = CPC 3-5	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of pulsatility index	Evaluate the association between pulsatility index and period of cardiac arrest	12 hours
Entry of doppler parameters	Identify a doppler parameter than can improve the neurological outcome	6 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Adel Maamar, Dr, Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: prognosis; Out-of-hospital cardiac arrest; cerebrovascular circulation; transcranial Doppler sonography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 35RC16_3047_DOTAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No