Study of the Natural Variation in Strokevolume

This study has been completed.

Sponsor:

Information provided by:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT00447200

First received: March 13, 2007

Last updated: October 12, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2007

Last Updated Date

October 12, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00447200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of the Natural Variation in Strokevolume

Official Title ^ICMJE

Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler

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.

Detailed Description

We would like to investigate the natural variation in the strokevolume(SV) 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 SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Stroke Volume Variation

Intervention ^ICMJE

Procedure: Esophagus Doppler monitoring
Procedure: Fluid optimization

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Planned abdominal surgery

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00447200

Other Study ID Numbers ^ICMJE

Validation of cycles

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Rigshospitalet, Denmark

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christoffer Jorgensen, M.S

Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej

Information Provided By

Rigshospitalet, Denmark

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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