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

Cardiac Arrest Clinical Trial

— DOTAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270683
• Other study ID #: 35RC16_3047_DOTAC
• Status: Completed
• Start date: May 2, 2016
• Est. completion date: October 2017

Study information

• Verified date: December 2019
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of pulsatility index	Evaluate the association between pulsatility index and period of cardiac arrest	12 hours
Secondary	Entry of doppler parameters	Identify a doppler parameter than can improve the neurological outcome	6 months