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CompletedNCT00771966Updated Oct 22, 2012

Radical Prostatectomy and Perioperative Fluid Therapy

A Phase 4 interventional study of Standard therapy and Maximization of cardiac stroke volume with fluid infusion in Prostate Cancer, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-10-22.

Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • patients with cancer in the prostate
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 44 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with cancer in there prostate

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Placebo comparator
    Standard treatment

    Procedure: Standard therapy

  • Active comparator
    SV maximization

    Procedure: Maximization of cardiac stroke volume with fluid infusion

Interventions

  • ProcedureStandard therapy

    Standard therapy

  • ProcedureMaximization of cardiac stroke volume with fluid infusion

    Maximization of cardiac stroke volume with fluid infusion

06

What researchers measure

Primary outcomes

  1. To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate

    Time frame: 6 hours

Secondary outcomes

  1. Investigate intraoperative haemodynamics

    Time frame: Intraoperative

07

Study locations

1 site
  • Dept of anesthesiology, Rigshospitalet
    Copenhagen, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00771966
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Morten Bundgaard-Nielsen (MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 15, 2008
Start date
Oct 2008
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Oct 22, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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