CompletedNot Applicable

The Effect of Lumbar CSF Drainage on the Neurologic Outcome Improvement in OHCA Underwent TTM

South Korea40 participantsStarted 2021-07-05

Plain-language summary

Aim: The investigators aim to evaluate the effect of lumbar cerebrospinal fluid (CSF) drainage on neurologic outcome in post-cardiac arrest (CA) patients treated with target temperature management (TTM). Methods: This is a prospective single-center study conducted from May 2020 to November 2021 on patients who have been treated with TTM following CA. The propensity score matching is proceeded between the lumbar CSF drainage and non-lumbar CSF drainage groups. The good outcome group is defined as a Glasgow-Pittsburgh cerebral performance categories (CPC) scale 1 or 2, and the poor outcome group as a CPC between 3 and 5. Lumbar CSF drainage is initiated when intracranial pressure (ICP) exceeded 15 mmHg in the absence of noxious stimuli at the rate of 10\~20 ml/h via a lumbar drainage catheter until ICP is less than 15 mmHg. The magnetic resonance imaging (MRI) is obtained between 72-96 h after return of spontaneous circulation (ROSC) to evaluate the effect of lumbar CSF drainage on attenuation of brain swelling through quantitative analysis of apparent diffusion coefficient (ADC). Multivariate logistic regression and Kaplan-Meier models are built to identify the effect of CSF drainage on the neurologic outcome improvement.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Resuscitated out of hospital cardiac arrest (OHCA) patients * OHCA patients whose GCS is 8 or less after ROSC * OHCA patients who undergo TTM Exclusion Criteria: * \< 18 y of age * Traumatic CA * Interrupted TTM due to hemodynamic instability * Intracranial hemorrhage * Active bleeding * Known terminal illness * Poor pre-arrest neurological status * Brain computed tomography showed severe cerebral edema * Brain computed tomography showed obliteration of the basal cisterns * Brain computed tomography showed occult intracranial mass lesion * Antiplatelet therapy * Anticoagulation therapy * Platelet count \< 40,000/mL * International normalized ratio (INR) \> 1.5 * OHCA patients on extracorporeal membrane oxygenation * There are no next of kin to consent to LP * Refusal of further treatment by the next of kin

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the effect of the lumbar CSF drainage on the neurologic outcome

Timeframe: 6 months after ROSC

Trial details

NCT IDNCT04328974

SponsorChungnam National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-02

View on ClinicalTrials.gov More Heart Arrest, Out-Of-Hospital trials