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Remote Ischaemic conditioning and Fentanyl as an adjunct to targeted temperature management in Hypoxic Brain Injury in post cardiac arrest patient

Remote Ischemic conditioning and fentanyl as an adjunct to targeted temperature management in hypoxic ischemic brain injury post cardiac Arrest (RESURRECT) Study. Hypoxic Ischemic Brain Injury (H1B1) Initiative: DBT, India - RESURRECT

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/023079
Enrollment
57
Registered
2020-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G931- Anoxic brain damage, not elsewhereclassified

Interventions

Intervention1: targeted temperature management, remote ischemic conditioning, fentanyl: each arm will receive either of targeted temperature management, targeted temperatrue management and RIC, target

Sponsors

Department of Biotechnology India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Both male and female patients of age >18 years 2.Successful resuscitation of in-hospital or out-hospital cardiac arrest of any cause 3.Glasgow coma scale of 8 or less at any time after restoration of spontaneous circulation 4.Prognosis after Resuscitation (PAR) score of 5.Presenting within first 6 hours of return of spontaneous circulation

Exclusion criteria

Exclusion criteria: 1.Pregnancy 2.Refractory Hypotension (Systolic blood pressure 3.Severe cardiac comorbidity 4.In-hospital comorbidities precluding the patient from hypothermia 5.On-going bleeding 6.Preexisting coma of other cause 7.Major surgery within last 14 days 8.Major head trauma 9.Family wishes goals of care as do not resuscitate 10.Traumatic arrest 11.Severe sepsis

Design outcomes

Primary

MeasureTime frame
The primary outcome is serum neuron specific enolase (NSE) at 72 hours after return of circulation.Timepoint: The primary outcome is serum neuron specific enolase (NSE) at 72 hours after return of circulation.

Secondary

MeasureTime frame
The secondary clinical outcome measures are mortality at 6 months, neurological disability at 6 months as assessed by modified Rankin scale, and cognitive dysfunction as assessed by Montreal cognitive assessment. The secondary imaging outcome measure include volume ischemic lesion at 1 week and cerebral atrophy at 6months assessed using MRI brain FLAIR sequence and T1 W MPRAGE sequence respectively.Timepoint: 6months

Countries

India

Contacts

Public ContactDr Rajeshwar

Christian Medical College and Hospital

jeyarajpandian@hotmail.com9915784750

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026