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NCT05032118: PENDULUM

Pilot Study of Ketamine Sedation for Aneurysmal Subarachnoid Hemorrhage

Withdrawn Phase 2, PHASE3 Last updated 1 May 2023
What this trial tests

Phase 2, PHASE3 trial testing Ketamine Hydrochloride in Subarachnoid Hemorrhage, Aneurysmal. Withdrawn.

Timeline
27 April 2023
Primary endpoint
27 April 2023
27 April 2023

Quick facts

Lead sponsorJenna L Leclerc MD, PhD
PhasePhase 2, PHASE3
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Start date27 April 2023
Primary completion27 April 2023
Estimated completion27 April 2023

Drugs / interventions tested

Conditions studied

Sponsor

Jenna L Leclerc MD, PhD

Who can join

Adults 18 to 80, any sex, with Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aneurysmal subarachnoid hemorrhage (aSAH) is bleeding into the space between the brain and the tissues that surround the brain as a result of a ruptured aneurysm and is a type of stroke associated with high morbidity and mortality. Those that survive the initial bleed are critically ill and require prolonged intensive care unit stays since they are at risk for a multitude of secondary insults that can further worsen functional outcomes. An especially feared secondary insult is delayed cerebral ischemia (DCI), which is a lack of blood flow to a particular portion of the brain that can result in an ischemic stroke and produce profound neurologic deficits. How DCI develops in some people after aSAH and not others is unknown, but many have hypothesized various mechanisms such as 1) cerebral vasospasm, a focal anatomic narrowing of the blood vessels in the brain that could decrease downstream blood flow, 2) abnormal electrical activity, and 3) microthrombi, or the formation of small blood clots. It is vitally important to identify a therapy that could protect the brain from these secondary insults that happen days after the initial brain bleed. Ketamine is a drug used in the majority of hospitals around the world for various indications, including general anesthesia, sedation, and for pain. Ketamine blocks a specific receptor that is present within the brain and in doing so could play a critical protective role against these secondary insults after aSAH by blocking the flow of dangerous chemicals. Ketamine may provide the following beneficial properties after aSAH: 1) pain control, 2) seizure prevention, 3) blood pressure support, 4) dilation of the brain blood vessels, 5) sedation, 6) anti-depressant, and 7) anti-inflammatory. This project is designed to test whether ketamine sedation in the intensive care unit after aneurysm repair provides better outcomes than the currently used sedation regimen.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Ketamine Hydrochloride

Trials testing the same drug.

Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05032118.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing