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Radical Prostatectomy and Perioperative Fluid Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morten Bundgaard-Nielsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00771966
First received: October 14, 2008
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Procedure: Standard therapy
Procedure: Maximization of cardiac stroke volume with fluid infusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radical Prostatectomy and Perioperative Fluid Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigate intraoperative haemodynamics [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771966

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

No publications provided

Responsible Party: Morten Bundgaard-Nielsen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00771966     History of Changes
Other Study ID Numbers: RCT_PROST_ORTO
Study First Received: October 14, 2008
Last Updated: October 19, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
patients with cancer in the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013