Radical Prostatectomy and Perioperative Fluid Therapy

October 19, 2012 updated by: Morten Bundgaard-Nielsen, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Dept of anesthesiology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigate intraoperative haemodynamics
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 19, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT_PROST_ORTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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