NCT00447200

Brief Summary

We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

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

Study Start

First participant enrolled

March 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 15, 2007

Status Verified

October 1, 2007

First QC Date

March 13, 2007

Last Update Submit

October 12, 2007

Conditions

Stroke Volume Variation

Keywords

Stroke volumeSV variationEsophagus DopplerGoal Directed Therapy

Outcome Measures

Primary Outcomes (3)

  • Strokevolume variation before fluid optimization

  • Strokevolume variation after fluid optimization

  • Number of cycles needed in order to detect a 10% strokevolume increase after fluid bolus of 200ml Voluven.

Interventions

Esophagus Doppler monitoringPROCEDURE
Fluid optimizationPROCEDURE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned abdominal surgery

You may not qualify if:

  • Oesophageal pathology,
  • Age \>90 yr or \<18 yr,
  • Alcohol abuse,
  • Aneurism in thoracic aorta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Region Sjælland, 2200, Denmark

Location

Study Officials

  • Christoffer Jorgensen, M.S

    Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 14, 2007

Study Start

March 1, 2007

Study Completion

August 1, 2007

Last Updated

October 15, 2007

Record last verified: 2007-10

Locations

DK(1)