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Study of the Natural Variation in Strokevolume

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447200
First Posted: March 14, 2007
Last Update Posted: October 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention
Stroke Volume Variation Procedure: Esophagus Doppler monitoring Procedure: Fluid optimization

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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.

Enrollment: 20
Study Start Date: March 2007
Study Completion Date: August 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Planned abdominal surgery

Exclusion Criteria:

  • Oesophageal pathology,
  • Age >90 yr or <18 yr,
  • Alcohol abuse,
  • Aneurism in thoracic aorta
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447200


Locations
Denmark
Rigshospitalet
Copenhagen, Seeland, Denmark, 2200
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christoffer Jorgensen, M.S Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
  More Information

ClinicalTrials.gov Identifier: NCT00447200     History of Changes
Other Study ID Numbers: Validation of cycles
First Submitted: March 13, 2007
First Posted: March 14, 2007
Last Update Posted: October 15, 2007
Last Verified: October 2007

Keywords provided by Rigshospitalet, Denmark:
Stroke volume
SV variation
Esophagus Doppler
Goal Directed Therapy