NCT03377049

Acetazolamide Challenge With Perfusion in the Prediction of Cerebral Vasospasm

Completed Phase 4 Results posted Last updated 27 July 2023

What this trial tests

Phase 4 trial testing Acetazolamide in Subarachnoid Hemorrhage, Aneurysmal in 11 participants. Completed in 15 July 2022.

Timeline

28 July 2019

Primary endpoint
15 July 2022

15 July 2022

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	11
Start date	28 July 2019
Primary completion	15 July 2022
Estimated completion	15 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Acetazolamide (ACETAZOLAMIDE) — full drug profile →

Conditions studied

• Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
• Vasospasm, Cerebral — all drugs for Vasospasm, Cerebral →

Sponsor

University of Wisconsin, Madison

Who can join

18 and older, any sex, with Subarachnoid Hemorrhage, Aneurysmal or Vasospasm, Cerebral. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Develop Delayed Cerebral Vasospasm Primary · Day 1-14 during the hospitalization

Clinical neurological deterioration not attributable to other causes, mores specifically not due to re-bleeding, hydrocephalus, or metabolic changes.

Group	Value	95% CI
Acetazolamide Challenge	2

Relative Percent Change in Cerebral Blood Flow Secondary · pre and post perfusion during imaging procedure, up to an hour

The data that will be statistically compared is the pre-diamox perfusion in comparison to the post-diamox perfusion. A statistically significant change increase in CBF represents an appropriate response to Diamox. Lack of change in CBF or decrease in CBF could be suggestive of potential for developing vasospasm.

Group	Value	95% CI
Acetazolamide Challenge	20.722	± 13.967

Percent Change in Left Hemisphere Brain Imaging Maps Secondary · pre and post perfusion during imaging procedure, up to an hour

Using perfusion map values, relative percent change will be calculated

Group	Value	95% CI
Acetazolamide Challenge	19.785	± 13.488

Percent Change in Right Hemisphere Brain Imaging Maps Secondary · pre and post perfusion during imaging procedure, up to an hour

Using perfusion map values, relative percent change will be calculated

Group	Value	95% CI
Acetazolamide Challenge	21.659	± 15.046

Adverse events — posted to ClinicalTrials.gov

Time frame: Days 1-14 during hospitalization. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Acetazolamide Challenge

Serious: 2/11 (18%)

Deaths: 1/11

Serious adverse events (3 terms)

Reaction	System	Acetazolamide Challenge
Cardiomyopathy	Cardiac disorders	—
External Ventricular Drainage infection	Nervous system disorders	—
Hydrocephalus	Nervous system disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Acetazolamide Challenge
Pulmonary edema	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Cardiomyopathy, External Ventricular Drainage infection, Hydrocephalus.

Data from ClinicalTrials.gov NCT03377049 adverse events section.

Sponsor's own description

The investigators propose a technique using cone beam CT perfusion (CBCTP) imaging with an acetazolamide challenge as a potential diagnostic tool to detect a defect in cerebral autoregulation at a time when it has not yet caused clinically apparent signs or symptoms. 30 participants will be enrolled at the University of Wisconsin - Madison and can expect to be on study for about 2 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.