- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435422
Neuroaxial Blokade and Blood Pressure
March 24, 2010 updated by: Rigshospitalet, Denmark
Neuroaxial Blokade and the Effect of Fluid Optimization
The effect of individualized fluid optimization during neuroaxial blockade has not been evaluated.
The investigators evaluated if if Stroke decrease 15 min after activation of neuroaxial blockade and whether SV could be optimized to pre activation values.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate SV maximization with aid of the LiDCO system which is a minimal invasive technique only requiring a venous and arterial line.
We thereby attempt to cover the specific individual fluid deficit induced by neuroaxial blockade.
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Morten Bundgaard-Nielsen, MD
- Phone Number: 0045 35 45 09 55
- Email: morten.bundgaard-nielsen@rh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet
-
Contact:
- Morten Bundgaard-Nielsen, MD
-
Contact:
- Hans-Jørgen B Frederiksen, MD
-
Principal Investigator:
- Morten Bundgaard-Nielsen, MD
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Neuroaxial blockade (thoracic)
Exclusion Criteria:
- Weight below 40 kg
- Lithium therapy
- Type I diabetes or type II requiring insulin
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stroke volume
Time Frame: 15 min after blockade
|
15 min after blockade
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain oxygenation, cardiac output, TPR, NIRS, BP
Time Frame: 15 min after blockade
|
15 min after blockade
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Morten Bundgaard-Nielsen, MD, Section of surgical pathophysiology
- Principal Investigator: Morten Bundgaard-Nielsen, MD, unafiliated
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
January 1, 2010
Primary Completion (Anticipated)
May 1, 2010
Study Completion (Anticipated)
May 1, 2010
Study Registration Dates
First Submitted
February 14, 2007
First Submitted That Met QC Criteria
February 14, 2007
First Posted (Estimate)
February 15, 2007
Study Record Updates
Last Update Posted (Estimate)
March 25, 2010
Last Update Submitted That Met QC Criteria
March 24, 2010
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neuroaxial blokade and BP
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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