Volume Deficit Prior to Surgery
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2006 | ||||
| Last Updated Date | August 5, 2009 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00380107 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 | Volume Deficit Prior to Surgery | ||||
| Official Title ICMJE | Estimation of Volume Deficit in Patients Prior to Surgery | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients for surgery in 3 procedures:
And 20 healthy subjects |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 4 | ||||
| Completion Date | August 2007 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 | NCT00380107 | ||||
| Other Study ID Numbers ICMJE | Opt. medium 1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Henrik Kehlet, Section of surgical pathophysiology | ||||
| Study Sponsor ICMJE | Rigshospitalet, Denmark | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rigshospitalet, Denmark | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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