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Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991157
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India

Brief Summary:
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.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage, Aneurysmal Drug: Nimodipine

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases
Actual Study Start Date : December 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Nimodipine




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    unit of measurement will be L/min

  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
aneurysmal subarachnoid hemorrhage with cerebral vasospasm
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991157


Locations
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India
NIMHANS
Bengaluru, India
Sponsors and Collaborators
National Institute of Mental Health and Neuro Sciences, India
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Responsible Party: Sriganesh Kamath, Associate Professor, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier: NCT02991157    
Other Study ID Numbers: 12.02
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India:
cerebral vasospasm
nimodipine
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nimodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents