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).
Condition or disease | Intervention/treatment | Phase |
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Cardiac Arrest Cerebral Lesion Ischemic Encephalopathy Ischemic Reperfusion Injury | Other: MAP increased to optimize cerebral blood flow Other: MAP between 65 and 85 mmHg | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study |
Estimated Study Start Date : | September 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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Experimental: Cerebral hypoperfusion (group A)
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.
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Other: MAP increased to optimize cerebral blood flow
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.
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Active Comparator: Normal cerebral perfusion (group B)
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.
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Other: MAP between 65 and 85 mmHg
MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.
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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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christelle Jadeau, PD | 0 (33) 2 43 43 43 43 ext 37 482 | cjadeau@ch-lemans.fr |
France | |
Centre Hospitalier Le Mans | |
Le Mans, France | |
Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 cjadeau@ch-lemans.fr | |
Principal Investigator: Nicolas Chudeau, MD |
Principal Investigator: | Nicolas Chudeau, MD | Centre Hospitalier Le Mans, Intensive Care Unit |
Tracking Information | |||||
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First Submitted Date ICMJE | June 22, 2019 | ||||
First Posted Date ICMJE | June 27, 2019 | ||||
Last Update Posted Date | June 27, 2019 | ||||
Estimated Study Start Date ICMJE | September 2019 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of patients in whom the transcranial doppler goal directed therapy will result in a modification of MAP targets [ Time Frame: In the first hour after inclusion ] Proportion of patients in whom transcranial doppler goal directed therapy will result in a modification of MAP targets.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study | ||||
Official Title ICMJE | Early Transcranial Doppler Goal Directed Therapy After Cardiac Arrest: a Pilot Study | ||||
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). |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04000334 | ||||
Other Study ID Numbers ICMJE | CHM-2019/S3/04 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier le Mans | ||||
Study Sponsor ICMJE | Centre Hospitalier le Mans | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier le Mans | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |