NCT00380107

Brief Summary

It is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery. The investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

10 months

First QC Date

September 22, 2006

Last Update Submit

August 5, 2009

Conditions

HypovolemiaSurgery

Keywords

Minor surgeryVolume optimizationVolume deficitEpidural anesthesia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients for surgery in 3 procedures: * mastectomy * rad. prostatectomy * open adb. surgery And 20 healthy subjects

You may qualify if:

  • Planned minor or medium sized surgery

You may not qualify if:

  • Oesophageal pathology
  • Age \>90 yr or \< 18 yr
  • Alcohol abuse,
  • Insulin dependent DM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, ABD centret, anaesthesiological dept. 2041

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • Bundgaard-Nielsen M, Jorgensen CC, Kehlet H, Secher NH. Normovolemia defined according to cardiac stroke volume in healthy supine humans. Clin Physiol Funct Imaging. 2010 Sep;30(5):318-322. doi: 10.1111/j.1475-097X.2010.00944.x. Epub 2010 Jun 10.

    PMID: 20545713DERIVED

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Morten Bundgaard-Nielsen, M.D.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 25, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

DK(1)