Last reviewed · How we verify
NCT05032118: PENDULUM
Pilot Study of Ketamine Sedation for Aneurysmal Subarachnoid Hemorrhage
Phase 2, PHASE3 trial testing Ketamine Hydrochloride in Subarachnoid Hemorrhage, Aneurysmal. Withdrawn.
27 April 2023
Quick facts
| Lead sponsor | Jenna L Leclerc MD, PhD |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Start date | 27 April 2023 |
| Primary completion | 27 April 2023 |
| Estimated completion | 27 April 2023 |
Drugs / interventions tested
- Ketamine Hydrochloride — full drug profile →
- Propofol (Propofol) — full drug profile →
Conditions studied
- Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
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.
Verify or expand the search:
- PubMed search for NCT05032118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketamine Hydrochloride
Trials testing the same drug.
- NCT05603104 — Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First- · Phase 3 · recruiting
- NCT06090422 — Ketamine for Combined Depression and Alcohol Use Disorder · Phase 1, PHASE2 · not yet recruiting
- NCT06496750 — Ketamine for Methamphetamine Use Disorder · Phase 2 · recruiting
- NCT05973851 — The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Us · Phase 3 · recruiting
- NCT06366334 — Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation · NA · recruiting
Other recruiting trials for Subarachnoid Hemorrhage, Aneurysmal
Currently open trials in the same condition.
- NCT04696523 — Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage · Phase 2 · recruiting
- NCT06819657 — Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid H · NA · recruiting
- NCT06766422 — AI Models for Cerebral Aneurysms Segmentation, Detection and Stability Prediction · recruiting
- NCT06906432 — Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage · recruiting
- NCT06218654 — Hemodynamic Instability of Patient With Spontaneous Subarachnoid Hemorrhage · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05032118 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jenna L Leclerc MD, PhD
- Last refreshed: 1 May 2023
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