- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02991157
Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
March 23, 2019 updated by: Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India
This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bengaluru, India
- NIMHANS
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
aneurysmal subarachnoid hemorrhage with cerebral vasospasm
Description
Inclusion Criteria:
- aneurysmal subarachnoid hemorrhage
- potential or actual cerebral vasospasm
Exclusion Criteria:
- non-aneurysmal subarachnoid hemorrhage
- outside the 4-21 day window after ictus
- peripheral deoxygenation
- contraindication for nimodipine administration
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Time Frame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
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Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the cardiac output measured using near NICOM technology after administration of nimodipine
Time Frame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
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unit of measurement will be L/min
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Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
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Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
Time Frame: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
|
Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2016
Primary Completion (ACTUAL)
November 1, 2018
Study Completion (ACTUAL)
December 1, 2018
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 9, 2016
First Posted (ESTIMATE)
December 13, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 23, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Subarachnoid Hemorrhage
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Nimodipine
Other Study ID Numbers
- 12.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Idorsia Pharmaceuticals Ltd.TerminatedAneurysmal Subarachnoid HemorrhageUnited States, Belgium, Taiwan, Canada, Hong Kong, Singapore, Germany, Netherlands, India, Czechia, Switzerland, France, Australia, Spain, Denmark, Finland, Argentina, Brazil, Sweden, Austria, Chile, Hungary, Israel, Italy, Mexico, Norway, ... and more
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