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NCT00435422 Clinical Trial

Neuroaxial Blokade and Blood Pressure

Hypovolemia Clinical Trial

Official title:
Neuroaxial Blokade and the Effect of Fluid Optimization

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00435422
Other study ID # Neuroaxial blokade and BP
Secondary ID
Status Recruiting
Phase N/A
First received February 14, 2007
Last updated March 24, 2010
Start date January 2010
Est. completion date May 2010

Study information
Verified date February 2009
Source Rigshospitalet, Denmark
Contact Morten Bundgaard-Nielsen, MD
Phone 0045 35 45 09 55
Email morten.bundgaard-nielsen@rh.dk
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 16
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Neuroaxial blockade (thoracic)

Exclusion Criteria:

- Weight below 40 kg

- Lithium therapy

- Type I diabetes or type II requiring insulin

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Stroke volume optimization
Stroke volume optimization

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Stroke volume 15 min after blockade No
Secondary Brain oxygenation, cardiac output, TPR, NIRS, BP 15 min after blockade No
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