Back to resultsNeuroaxial Blokade and Blood Pressure
Primary Purpose
Hypovolemia
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Stroke volume optimization
Sponsored by
About this trial
This is an interventional treatment trial for Hypovolemia
Eligibility Criteria
Inclusion Criteria:
- Neuroaxial blockade (thoracic)
Exclusion Criteria:
- Weight below 40 kg
- Lithium therapy
- Type I diabetes or type II requiring insulin
Sites / Locations
- RigshospitaletRecruiting
Outcomes
Primary Outcome Measures
Stroke volume
Secondary Outcome Measures
Brain oxygenation, cardiac output, TPR, NIRS, BP
Full Information
NCT ID
NCT00435422
First Posted
February 14, 2007
Last Updated
March 24, 2010
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00435422
Brief Title
Neuroaxial Blokade and Blood Pressure
Official Title
Neuroaxial Blokade and the Effect of Fluid Optimization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Stroke volume optimization
Intervention Description
Stroke volume optimization
Primary Outcome Measure Information:
Title
Stroke volume
Time Frame
15 min after blockade
Secondary Outcome Measure Information:
Title
Brain oxygenation, cardiac output, TPR, NIRS, BP
Time Frame
15 min after blockade
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neuroaxial blockade (thoracic)
Exclusion Criteria:
Weight below 40 kg
Lithium therapy
Type I diabetes or type II requiring insulin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Bundgaard-Nielsen, MD
Phone
0045 35 45 09 55
Email
morten.bundgaard-nielsen@rh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Bundgaard-Nielsen, MD
Organizational Affiliation
Section of surgical pathophysiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morten Bundgaard-Nielsen, MD
Organizational Affiliation
unafiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Bundgaard-Nielsen, MD
First Name & Middle Initial & Last Name & Degree
Hans-Jørgen B Frederiksen, MD
First Name & Middle Initial & Last Name & Degree
Morten Bundgaard-Nielsen, MD
12. IPD Sharing Statement
Learn more about this trial
Neuroaxial Blokade and Blood Pressure
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