Therapeutic Hypothermia and eArly Waking

NCT ID: NCT03065946

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2018-02-28

Brief Summary

Unconscious survivors of cardiac arrest who are treated with intravenous therapeutic hypothermia for 24 hours will be assessed after 12 hours for appropriateness to be woken early and extubated whilst continuing to receive therapeutic hypothermia. Sedation will be reduced/stopped at 12 hours to enable a comprehensive neurological assessment utilising a multimodal approach.

Providing the patient is clinically stable with no adverse neurological signs the patient will be extubated. Patients who remain unconscious will be reviewed 6 hourly for neurological recovery and their suitability to be extubated in line with standard practice.

Detailed Description

This study is a single centre, prospective, feasibility and safety study. Consecutively enrolling 50 patients. Subjects will include adult patients who have suffered a cardiac arrest with a return of spontaneous circulation (ROSC).

To qualify, patients must be unconscious and intubated because their initial Glasgow Coma Score (GCS) is <8. Intravenous therapeutic hypothermia (TH) will be established in the cathlab and maintained for 24 hours whilst being cared for in the intensive Care Unit (ICU). IVTM will maintain the patient's core temperature at a target temperature between 32-34 degrees Celsius. After the patient has received 12 hours of TH, sedation will be stopped and the patient will have a comprehensive neurological assessment combining electroencephalogram (EEG), Somatic Sensory Evoked Potential (SSEP) and neurological biomarkers, Neuron Specific Enolase (NSE) and S100b. The EEG, SSEP and biomarkers will be reviewed by an expert in neurophysiology at a core lab off-site. These results will be reviewed retrospectively, therefore will not influence the medical management of the patient.

Patients who are clinically stable and not showing any adverse neurological signs will be extubated after 12 hours. Patients who don't meet the early waking criteria will reassessed every 6 hours for extubation. Those patients who are not suitable to be woken early or remain unconscious after 24 hours will be reassessed as per standard practice for unconscious survivors of cardiac arrest.

Conditions

Out of Hospital Cardiac Arrest; Brain Injury

Keywords

Therapeutic hypothermia; Electroencephalogram; Neuron-Specific Enolase; Return of Spontaneous Circulation; S-100B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case series

Early wakening

Early wakening

Intervention Type: OTHER

By using an intravascular device to administer mild TH for 24 hours, patients can safely have their medically induced coma reversed early at 12 hours, allowing an accurate neurological assessment to be performed

Interventions

Early wakening

By using an intravascular device to administer mild TH for 24 hours, patients can safely have their medically induced coma reversed early at 12 hours, allowing an accurate neurological assessment to be performed

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Post cardiac arrest with ROSC
• Planning to receive MTH as part of post-cardiac arrest care

Exclusion Criteria

• Cardiac arrest caused by trauma, head injury, massive haemorrhage, drug overdose, cerebrovascular accident, drowning, electric shock or hanging.
• Do Not Attempt to Resuscitate (DNAR) orders
• Known terminal illness (e.g. malignancy in the end stages)
• Known or obvious pregnancy
• Known coagulation disorder (except those induced by medication)
• Known oxygen dependency
• The patient has a height of <1.5 meters (4 feet 11 inches)
• The patient has a known hypersensitivity to Buspirone Hydrochloride or Pethidine
• Patient has a known history of severe hepatic or renal impairment, untreated hypothyroidism, Addison's disease, benign prostatic hypertrophy, or urethral stricture that in the opinion of the treating consultant would be incompatible with Pethidine administration
• The patient has an inferior Vena Cava (IVC) filter in place
• The patient has a known, unresolved history of drug use or alcohol dependency, or lacks the ability to comprehend or follow instructions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Keeble, MBBS MD MRCP

Role: PRINCIPAL_INVESTIGATOR

Basildon and Thurrock University Hospitals NHS FT

Locations

The Essex Cardiothoracic Centre

Basildon, Essex, United Kingdom

Countries

United Kingdom

Other Identifiers

B784

Identifier Type: -

Identifier Source: org_study_id