Back to results

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study (GOODYEAR)

Primary Purpose

Cardiac Arrest, Cerebral Lesion, Ischemic Encephalopathy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MAP increased to optimize cerebral blood flow

MAP between 65 and 85 mmHg

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, cerebral blood flow, cerebral autoregulation, transcranial doppler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation with a Glasgow Coma Scale ≤ 8/15 after in- or out-of-hospital cardiac arrest
Mean arterial pressure between 65 and 85 mmHg with or without vasopressor support

Exclusion Criteria:

Age < 18 years old
No flow (time between cardiac arrest and the beginning of cardiac massage) > 15 minutes or unknown
Low flow ((time between cardiac arrest and ROSC: return of spontaneous circulation)> 60 minutes
Time between ROSC and inclusion > 12 hours
Transcranial doppler unavailable
Cardiac arrythmia
Patient under extracorporeal life support before inclusion or at risk of being referred for assistance due to cardiogenic shock with high dose of vasopressors before inclusion (MAP < 65 mmHg with norepinephrine or epinephrine > 1 µg/kg/min or dobutamine > 10 µg/kg/min)
Severe cardiac dysfunction defined by left ventricular ejection fraction < 20% or aortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) < 14 cm with dobutamine > 10µg/kg/min
Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Distress Syndrome (ARDS) before inclusion
Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage or traumatic brain injury
Hemorrhagic shock
Any acute pathology that requires strict blood pressure control (aortic dissection, stroke, cardiogenic pulmonary edema with high blood pressure)
Decision of withdrawing or withholding life sustaining treatment before inclusion or considered during the first 12 hours of ICU management
Patient with a modified Rankin scale (MRS) 4 or 5 prior to resuscitation
Pregnancy or lactation
Patients already enrolled in another clinical study on cardiac arrest
Patients with judicial protection
No social security coverage

Sites / Locations

Centre Hospitalier Le MansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cerebral hypoperfusion (group A)

Normal cerebral perfusion (group B)

Arm Description

Cerebral hypoperfusion will be defined by an abnormal TCD at inclusion (t0) when two of the three measured values are abnormal using the following thresholds: Vm < 30 cm/s, Vd < 20 cm/s, PI > 1.4.

Normal cerebral perfusion will be defined by a normal TCD at inclusion (t0) when two of the three measured values are normal using the following thresholds: Vm > 30 cm/s, Vd > 20 cm/s, PI < 1.4.

Outcomes

Primary Outcome Measures

Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets

Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.

Secondary Outcome Measures

Cerebral blood flow modifications induced by increasing MAP

Transcranial doppler data modifications induced by increasing MAP to 90-100 mmHg and 100-110 mmHg.

Cerebral oxygenation modifications induced by increasing MAP

Bulb jugular venous oxygen saturation modifications induced by increasing MAP at 90-100 mmHg and 100-110 mmHg.

Undesirable events induced by increasing MAP

Number of cardiovascular events defined by new onset of severe cardiac arrythmias, acute coronary syndromes, cardiogenic pulmonary edema, cardiogenic shock or cardiac arrest

Undesirable events induced by increasing MAP

Number of neurologic events defined by intracranial hematoma or brain death

Plasmatic concentrations of Neuron Specific Enolase

Neuron Specific Enolase (NSE) plasmatic concentrations at H+72h after cardiac arrest

28 day survival

Proportion of patients alive 28 days after inclusion

90 days survival

Proportion of patients alive 90 days after inclusion

Measure of the degree of disability in the activities of daily living of the included patients

Modified Rankin scale (MRS) 90 days after inclusion. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead.

Full Information

NCT ID

NCT04000334

First Posted

June 22, 2019

Last Updated

March 8, 2022

Sponsor

Centre Hospitalier le Mans

1. Study Identification

Unique Protocol Identification Number

NCT04000334

Brief Title

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

Acronym

GOODYEAR

Official Title

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2020 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier le Mans

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Hypoxic-ischaemic brain injury (HIBI) is the main cause of death in patients who are comatose after resuscitation from cardiac arrest. Current guidelines recommend to target a mean arterial pressure (MAP) above 65 mmHg to achieve an adequate organ perfusion. Moreover, after cardiac arrest, cerebral autoregulation is dysregulated and cerebral blood flow (CBF) depends on the MAP. A higher blood pressure target could improve cerebral perfusion and HIBI. Transcranial Doppler (TCD) is a non-invasive method to study CBF and its variations induced by MAP. The aim of this study is to test the feasibility of an early-goal directed hemodynamic management with TCD during the first 12 hours after return of spontaneous circulation (ROSC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest, Cerebral Lesion, Ischemic Encephalopathy, Ischemic Reperfusion Injury

Keywords

cardiac arrest, cerebral blood flow, cerebral autoregulation, transcranial doppler

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cerebral hypoperfusion (group A)

Arm Type

Experimental

Arm Description

Cerebral hypoperfusion will be defined by an abnormal TCD at inclusion (t0) when two of the three measured values are abnormal using the following thresholds: Vm < 30 cm/s, Vd < 20 cm/s, PI > 1.4.

Arm Title

Normal cerebral perfusion (group B)

Arm Type

Active Comparator

Arm Description

Normal cerebral perfusion will be defined by a normal TCD at inclusion (t0) when two of the three measured values are normal using the following thresholds: Vm > 30 cm/s, Vd > 20 cm/s, PI < 1.4.

Intervention Type

Other

Intervention Name(s)

MAP increased to optimize cerebral blood flow

Intervention Description

MAP will be increased to 90-100 mmHg with norepinephrine. If TCD is still abnormal with a MAP of 90-100 mmHg, MAP will be increased to 100-110 mmHg. At each step, all CBF determinants will be recorded as well as cardiac output and Veinous jugular oxygen saturation (SvjO2). When TCD is normalized with no complications, MAP will be maintained at 90-100 or 100-110 mmHg during 24 hours.

Intervention Type

Other

Intervention Name(s)

MAP between 65 and 85 mmHg

Intervention Description

MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.

Primary Outcome Measure Information:

Title

Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets

Description

Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.

Time Frame

In the first hour after inclusion

Secondary Outcome Measure Information:

Title

Cerebral blood flow modifications induced by increasing MAP

Description

Transcranial doppler data modifications induced by increasing MAP to 90-100 mmHg and 100-110 mmHg.

Time Frame

At the 6th, 12th, 24th, 48th and 72nd hour after inclusion

Title

Cerebral oxygenation modifications induced by increasing MAP

Description

Bulb jugular venous oxygen saturation modifications induced by increasing MAP at 90-100 mmHg and 100-110 mmHg.

Time Frame

At the 6th, 12th, 24th, 48th and 72nd hour after inclusion

Title

Undesirable events induced by increasing MAP

Description

Number of cardiovascular events defined by new onset of severe cardiac arrythmias, acute coronary syndromes, cardiogenic pulmonary edema, cardiogenic shock or cardiac arrest

Time Frame

At te 24th hour after inclusion

Title

Undesirable events induced by increasing MAP

Description

Number of neurologic events defined by intracranial hematoma or brain death

Time Frame

At the 72nd hour after inclusion

Title

Plasmatic concentrations of Neuron Specific Enolase

Description

Neuron Specific Enolase (NSE) plasmatic concentrations at H+72h after cardiac arrest

Time Frame

At the 72nd hour after inclusion

Title

28 day survival

Description

Proportion of patients alive 28 days after inclusion

Time Frame

28 days after inclusion

Title

90 days survival

Description

Proportion of patients alive 90 days after inclusion

Time Frame

90 days after inclusion

Title

Measure of the degree of disability in the activities of daily living of the included patients

Description

Time Frame

90 days after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients admitted in the Intensive Care Unit (ICU) under mechanical ventilation with a Glasgow Coma Scale ≤ 8/15 after in- or out-of-hospital cardiac arrest Mean arterial pressure between 65 and 85 mmHg with or without vasopressor support Exclusion Criteria: Age < 18 years old No flow (time between cardiac arrest and the beginning of cardiac massage) > 15 minutes or unknown Low flow ((time between cardiac arrest and ROSC: return of spontaneous circulation)> 60 minutes Time between ROSC and inclusion > 12 hours Transcranial doppler unavailable Cardiac arrythmia Patient under extracorporeal life support before inclusion or at risk of being referred for assistance due to cardiogenic shock with high dose of vasopressors before inclusion (MAP < 65 mmHg with norepinephrine or epinephrine > 1 µg/kg/min or dobutamine > 10 µg/kg/min) Severe cardiac dysfunction defined by left ventricular ejection fraction < 20% or aortic Velocity Time Integral (VTI: measured with trans-thoracic echocardiography) < 14 cm with dobutamine > 10µg/kg/min Patient under Extracorporeal Membrane Oxygenation (ECMO) for Acute Respiratory Distress Syndrome (ARDS) before inclusion Cardiac arrest secondary to brain injury such as stroke, subarachnoid hemorrhage or traumatic brain injury Hemorrhagic shock Any acute pathology that requires strict blood pressure control (aortic dissection, stroke, cardiogenic pulmonary edema with high blood pressure) Decision of withdrawing or withholding life sustaining treatment before inclusion or considered during the first 12 hours of ICU management Patient with a modified Rankin scale (MRS) 4 or 5 prior to resuscitation Pregnancy or lactation Patients already enrolled in another clinical study on cardiac arrest Patients with judicial protection No social security coverage

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christelle Jadeau, PD

Phone

0 (33) 2 43 43 43 43

Ext

37 482

cjadeau@ch-lemans.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Chudeau, MD

Organizational Affiliation

Centre Hospitalier Le Mans, Intensive Care Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Le Mans

City

Le Mans

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christelle Jadeau, PD

Phone

0 (33) 2 43 43 43 43

Ext

37 482

cjadeau@ch-lemans.fr

First Name & Middle Initial & Last Name & Degree

Nicolas Chudeau, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study

We'll reach out to this number within 24 hrs