CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
lumbar CSF drainageprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04328974
NCT04328974N/ACompleted

The Effect of Lumbar Cerebrospinal Fluid Drainage on the Neurologic Outcome Improvement in Out of Hospital Cardiac Arrest Patients Underwent Targeted Temperature Management

Chungnam National University Hospital·observational·Posted Apr 1, 2020·Updated Feb 9, 2024

In Brief

An observational study evaluating lumbar CSF drainage for Heart Arrest, Out-Of-Hospital and Brain Swelling. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 1, 2020
Enrollment StartJul 5, 2021
Primary CompletionApr 2, 2023
Study CompletionJan 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.3 years ago

Interventions

lumbar CSF drainageprocedure

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 \[14, 15\].