Volume Deficit Prior to Surgery

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00380107
First received: September 22, 2006
Last updated: August 5, 2009
Last verified: August 2009

September 22, 2006
August 5, 2009
October 2006
August 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00380107 on ClinicalTrials.gov Archive Site
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Volume Deficit Prior to Surgery
Estimation of Volume Deficit in Patients Prior to Surgery

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.

Intravascular volume optimization has shown to improve outcome after surgery. In minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. Patient scheduled for minor surgery are included. After the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally invasive method.

The volume estimated for optimization is considered as the functional volume deficit.

In the healthy subjects the probe will be placed in the awake subject. A standardized meal and fluid intake secures that the subjects are in a non-fasting state.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients for surgery in 3 procedures:

  • mastectomy
  • rad. prostatectomy
  • open adb. surgery

And 20 healthy subjects

  • Hypovolemia
  • Surgery
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Bundgaard-Nielsen M, Jørgensen CC, Kehlet H, Secher NH. Normovolemia defined according to cardiac stroke volume in healthy supine humans. Clin Physiol Funct Imaging. 2010 Sep;30(5):318-22. Epub 2010 Jun 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
August 2007
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Planned minor or medium sized surgery

Exclusion Criteria:

  • Oesophageal pathology
  • Age >90 yr or < 18 yr
  • Alcohol abuse,
  • Insulin dependent DM
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00380107
Opt. medium 1
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Henrik Kehlet, Section of surgical pathophysiology
Rigshospitalet, Denmark
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Principal Investigator: Morten Bundgaard-Nielsen, M.D. Rigshospitalet, Denmark
Rigshospitalet, Denmark
August 2009

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