NCT00435422

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 25, 2010

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 14, 2007

Last Update Submit

March 24, 2010

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (1)

  • Stroke volume

    15 min after blockade

Secondary Outcomes (1)

  • Brain oxygenation, cardiac output, TPR, NIRS, BP

    15 min after blockade

Interventions

Stroke volume optimizationPROCEDURE

Stroke volume optimization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neuroaxial blockade (thoracic)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Morten Bundgaard-Nielsen, MD

    Section of surgical pathophysiology

    PRINCIPAL INVESTIGATOR

  • Morten Bundgaard-Nielsen, MD

    unafiliated

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Bundgaard-Nielsen, MD

CONTACT

0045 35 45 09 55morten.bundgaard-nielsen@rh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

March 25, 2010

Record last verified: 2009-02

Locations

DK(1)