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Radical Prostatectomy and Perioperative Fluid Therapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Standard therapy
Maximization of cardiac stroke volume with fluid infusion
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring patients with cancer in the prostate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of anesthesiology, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard treatment

SV maximization

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Investigate intraoperative haemodynamics

Full Information

First Posted
October 14, 2008
Last Updated
October 19, 2012
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00771966
Brief Title
Radical Prostatectomy and Perioperative Fluid Therapy
Official Title
Radical Prostatectomy and Perioperative Fluid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
patients with cancer in the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Placebo Comparator
Arm Title
SV maximization
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Standard therapy
Intervention Description
Standard therapy
Intervention Type
Procedure
Intervention Name(s)
Maximization of cardiac stroke volume with fluid infusion
Intervention Description
Maximization of cardiac stroke volume with fluid infusion
Primary Outcome Measure Information:
Title
To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Investigate intraoperative haemodynamics
Time Frame
Intraoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dept of anesthesiology, Rigshospitalet
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

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Radical Prostatectomy and Perioperative Fluid Therapy

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