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Radical Prostatectomy and Perioperative Fluid Therapy

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ClinicalTrials.gov Identifier: NCT00771966
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
Morten Bundgaard-Nielsen, Rigshospitalet, Denmark

Brief Summary:

The optimal amount of fluid a patient need under surgery is not clear. Both to much and to little fluid can damage the organ functions.

A strategy called "Goal directed therapy", where the fluid amount a patient need is guided by the stroke volume, has shown to minimize post-operative nausea and vomiting.

The investigators intend to investigate if patients treated after these standards, has a better outcome then patients treated after normal regimes, regarding post-operative orthostatic-intolerance.


Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Standard therapy Procedure: Maximization of cardiac stroke volume with fluid infusion Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radical Prostatectomy and Perioperative Fluid Therapy
Study Start Date : October 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Standard treatment Procedure: Standard therapy
Standard therapy
Active Comparator: SV maximization Procedure: Maximization of cardiac stroke volume with fluid infusion
Maximization of cardiac stroke volume with fluid infusion



Primary Outcome Measures :
  1. To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Investigate intraoperative haemodynamics [ Time Frame: Intraoperative ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cancer in there prostate

Exclusion Criteria:

  • Patients who don't understand the information
  • ASA > III
  • Patients that are under treatment with the drug triazolam
  • Patients with af known renal decease
  • Patients with a psychiatric decease
  • Alcohol abuse
  • Severe haemorrhagic decease
  • Cancer in the mouth,pharynx, larynx or oesophagus

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): NCT00771966


Locations
Denmark
Dept of anesthesiology, Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Morten Bundgaard-Nielsen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00771966     History of Changes
Other Study ID Numbers: RCT_PROST_ORTO
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Morten Bundgaard-Nielsen, Rigshospitalet, Denmark:
patients with cancer in the prostate