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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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014