Phase 1
N=7
Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study
Cerebral Hemorrhage · Cerebral Edema · Intracerebral Hemorrhage · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03000283 ↗Enrolled (actual)
7
Serious AEs
100.0%
Results posted
Apr 2020
Primary outcome: Primary: Patient Tolerance of Conivaptan — 0; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Conivaptan (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Jesse Corry
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Tolerance of Conivaptan |
0; 0; 1; 0 | — |
| SECONDARY In-hospital Mortality |
— | — |
| SECONDARY Change in Cerebral Edema |
-37.1 | — |
| SECONDARY Cost |
0; 7; 1 | — |
| SECONDARY Cost |
0; 7; 1 | — |
| SECONDARY Modified Rankin Scale (mRS) Score |
5 | — |
Summary
The goal of this study is to preliminarily determine/estimate feasibility and whether frequent and early conivaptan use, at a dose currently determined to be safe (i.e., 40mg/day), is safe and well-tolerated in patients with cerebral edema from intracerebral hemorrhage (ICH) and pressure (ICP). A further goal is to preliminarily estimate whether conivaptan at this same dose can reduce cerebral edema (CE) in these same patients. This study is also an essential first step in understanding the role of conivaptan in CE management.
Hypothesis: The frequent and early use of conivaptan at 40mg/day will be safe and well-tolerated, and also reduce cerebral edema, in patients with intracerebral hemorrhage and pressure.
Eligibility Criteria
Inclusion Criteria
- Age >18 years old and 20 cc in volume.
- Enrollment within 48 hours from initial symptoms.
- Signed informed consent from the patient or obtained via their legally authorized representative (if the patient is not able to sign the informed consent themselves). The patient's decisional capacity to either provide or refuse consent will be determined using the Glasgow Coma Scale (GCS), which is being assessed at baseline and at 24 hours (+/-6hrs) after enrollment. A potential study participant with a GCS > 14 will be asked to provide their own initial study consent. A GCS ≤ 14 would indicate the need to pursue consent via legally authorized representative.
Exclusion Criteria
- Current need for renal replacement therapy (RRT).
- Glomerular filtration rate (GFR) of 160 units/L and/or alanine transaminase (ALT) >180 units/L, or total bilirubin levels greater than four times normal levels (>4.8mg/dL).
- Serum Na+> 145 mmol/L (admission labs or any time prior to recruitment/enrollment).
- Unable to receive conivaptan based on contraindications indicated by the manufacturer.
- Pregnant or lactating females.
- Not expected to survive within 48 hours of admission, or a presumed diagnosis of brain death.
Data sourced from ClinicalTrials.gov (NCT03000283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.