Neuroaxial Blokade and Blood Pressure | NCT00435422

Studies
Neuroaxial Blokade and Blood Pressure

NCT00435422

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Mar 25, 2010Estimated

Enrollment

16Estimated

Phase

Not Applicable

Conditions

Hypovolemia

Interventions

Stroke volume optimization

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Feb 14, 2007

First Submission Date that Met QC Criteria

Feb 14, 2007

First Posted Date

Feb 15, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2010

Last Update Posted Date

Mar 25, 2010Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stroke volume optimization	Procedure	Stroke volume optimization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke volume		15 min after blockade

Secondary Outcomes

Measure	Description	Time Frame
Brain oxygenation, cardiac output, TPR, NIRS, BP		15 min after blockade

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Neuroaxial blockade (thoracic)

Exclusion Criteria:

Weight below 40 kg
Lithium therapy
Type I diabetes or type II requiring insulin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Morten Bundgaard-Nielsen, MD	Contact	0045 35 45 09 55		morten.bundgaard-nielsen@rh.dk

Overall Officials

Name	Affiliation	Role
Morten Bundgaard-Nielsen, MD	Section of surgical pathophysiology	Principal Investigator
Morten Bundgaard-Nielsen, MD	unafiliated	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet	Recruiting	Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020896	Hypovolemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided