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

NCT04328974 | Completed

• 1 other identifier: 201907033003
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Arrest, Out-Of-Hospital; Brain Swelling

Keywords

lumbar; intracranial pressure

Outcome Measures

Primary Outcomes (1)

• the effect of the lumbar CSF drainage on the neurologic outcome

  The primary endpoint is to mearsure the effect of the lumbar CSF drainage on the neurologic outcome using the Glasgow Pittsburgh cerebral performance category (CPC) scale in post-CA patients treated with TTM.

  6 months after ROSC

Secondary Outcomes (1)

• the effect of the lumbar CSF drainage on attenuation of brain swelling

  72-96 hours after ROSC

Study Arms (1)

the lumbar CSF drainage group

We named the patients treated with the protocol and the lumbar CSF drainage as the lumbar CSF drainage group.

Procedure: lumbar CSF drainage

Interventions

lumbar CSF drainage PROCEDURE

We have performed the lumbar CSF drainage on the level of the lumbar spine between L3 and L4 with the patient lying in the lateral decubitus position with hips and knees flexed. A lumbar drainage catheter was inserted using a HermeticTM lumbar accessory kit (Integra Neurosciences, Plainsboro, NJ, USA) in the patients. ICP monitoring via lumbar drainage catheter was practiced using the LiquoGuard® (Möller Medical GmbH \& Co KG, Fulda, Germany). ICP control strategies was initiated when 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 was less than 15 mmHg \[14, 15\].

the lumbar CSF drainage group

Eligibility Criteria

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

Study Population

A previous study reported ICP on 24 h after ROSC was 189.00 ± 46.02 mmH2O in good outcome and 265.56 ± 72.43 mmH2O in poor outcome, 40 patients were needed to achieve the power of 0.90 at a significance level of 0.01 (two-sided test).

You may qualify if:

• Resuscitated out of hospital cardiac arrest (OHCA) patients
• OHCA patients whose GCS is 8 or less after ROSC
• OHCA patients who undergo TTM

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Chungnam National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

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MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Brain Edema

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yeonho You, professor

  Chungnam National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 1, 2020
• Study Start: July 5, 2021
• Primary Completion: April 2, 2023
• Study Completion: January 16, 2024
• Last Updated: February 9, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)