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NCT04156490 · ClinicalTrials.gov registry record
Osmotic Agent Use in Middle Cerebral Artery Stroke
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 100
- Enrollment target
NCT04156490: Completed study, sponsored by University of Minnesota.
NCT04156490 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04156490 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
This is a retrospective chart review of patients that were admitted with large MCA stroke to the Fairview system hospitals between December 2017-December 2018. Patients ischemic stroke volumes will be measured by taking the area of the infarction and multiplying it by the thickness of each CT or MRI slice, the summation of these volumes is the final volume of the ischemic lesion in cubic centimeters. Patients with stroke volumes greater than 70 cc will be included in the study. Patient midline shift will be measured in millimeters at the level of foramen of Monroe anytime during their initial admission and all patients with a shift greater than 1mm will be included. The midline shift will be documented on the first follow-up brain scan (CT or MRI) at least six hours after the initiation of osmotic therapy. Data will be collected from patient charts including: Age, sex, NIHSS on presentation and discharge, history of diabetes mellitus, hypertension, coronary artery disease, atrial fibrillation, and chronic kidney disease. The type of osmotherapy, along with change in serum sodium or osmolality and dose, will also be documented. In patients that did not receive osmotherapy, midline shift will be documented on the first 24-hour scan and every subsequent scan in 24-hour intervals. Death during a hospital stay will also be recorded. The investigators will use the SAS statistical suite to analyze this data.
Primary Outcome
Change of midline shift in millimeters at foramen of Monroe level, at six hours or after osmotherapy in the Acute MCA syndrome of greater than 70cc in volume
Interventions
- OTHER No intervention is planned, this will be a purely retrospective trial.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-02-10 |
| Est. Completion | 2019-06-30 |
What the finished NCT04156490 record still lists
NCT04156490 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which No intervention is planned, this will be a purely retrospective trial. is the first listed.
NCT04156490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04156490 about?
NCT04156490 is a clinical study titled "Osmotic Agent Use in Middle Cerebral Artery Stroke". This is a retrospective chart review of patients that were admitted with large MCA stroke to the Fairview system hospitals between December 2017-December 2018. Patients ischemic stroke volumes will be measured by taking the area of the infarction and multiplying it by the thickness of each CT or MRI...
What is the current status of trial NCT04156490?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2018-02-10. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT04156490?
The interventions under investigation include: No intervention is planned, this will be a purely retrospective trial. (OTHER).
Who is sponsoring clinical trial NCT04156490?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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