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

• Sponsor: National Institute of Mental Health and Neuro Sciences, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT02991157
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Phase
Subarachnoid Hemorrhage, Aneurysmal	Drug: Nimodipine

Study Design

• 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: Dec 1, 2016
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine [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 [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 [Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NIMHANS	Bengaluru		India

Sponsors and Collaborators

• National Institute of Mental Health and Neuro Sciences, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 13, 2016
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Sriganesh Kamath, Associate Professor, National Institute of Mental Health and Neuro Sciences, India: cerebral vasospasm; nimodipine
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hemorrhage; Nimodipine

Study Results

No Results Posted as of Mar 26, 2019