Osmotic Agent Use in Middle Cerebral Artery Stroke

NCT04156490 | Completed DMC

• 1 other identifier: STUDY00001221
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; MCA Infarction

Keywords

Ischemic stroke; midline shift

Outcome Measures

Primary Outcomes (1)

• Midline shift

  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

  Six hour or after administration of hyperosmolar therapy

Secondary Outcomes (1)

• In-Hospital Mortality

  Length of hospital stay, 4 weeks

Other Outcomes (1)

• Change in National Institutes of Health Stroke Scale (NIHSS)

  Length of hospital stay, 4 weeks

Interventions

No intervention is planned, this will be a purely retrospective trial. OTHER

Osmotic Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ischemic Stroke patients with large MCA territory Stroke of 70 CC or larger.

You may qualify if:

• MCA stroke greater than 70cc in size.
• Patients with a midline shift \> 1 mm
• Age 18-80 years old

You may not qualify if:

• Hemorrhagic conversion (PH2 or higher. )
• Hemicraniectomy within 6 hours from initiation of hypertonic therapy
• Hemicraniectomy with no repeat CT imaging prior to the operation
• Hemicraniectomy emergently without hypertonic therapy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rwoof A Reshi, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: November 7, 2019
• Study Start: February 10, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)