Therapeutic Hypothermia and eArly Waking

NCT03065946 | Completed DMC

• 1 other identifier: B784
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Out of Hospital Cardiac Arrest; Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The number of unconscious survivors following an OHCA, who are admitted to the ICU being treated with MTH who are clinically stable can be safely woken and extubated after 12 hours whilst continuing to receive therapeutic hypothermia.

  Is it safe and feasible to wake patients early whilst receiving therapeutic hypothermia to assess their neurological function?

  12 hours

Secondary Outcomes (8)

• Reduction in ICU and hospital stay

  24 hours

• Reduction of Neurological recovery at 12 hours

  24 hours

• Reduction in the time to perform a CPC assessment

  24 days

• NSE and S100B values during early waking phase

  2 days

• Composite outcome off all-cause mortality and poor neurological function

  7 days

Study Arms (1)

Case series

Early wakening

Other: Early wakening

Interventions

Early wakening 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

Case series

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiac arrest

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Brain Injuries

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Thomas Keeble, MBBS MD MRCP

  Basildon and Thurrock University Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 28, 2017
• Study Start: February 10, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)