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Radical Prostatectomy and Perioperative Fluid Therapy

NCT ID: NCT00771966

Last Updated: 2012-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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patients with cancer in the prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard treatment

Group Type PLACEBO_COMPARATOR

Standard therapy

Intervention Type PROCEDURE

Standard therapy

SV maximization

Group Type ACTIVE_COMPARATOR

Maximization of cardiac stroke volume with fluid infusion

Intervention Type PROCEDURE

Maximization of cardiac stroke volume with fluid infusion

Interventions

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Standard therapy

Standard therapy

Intervention Type PROCEDURE

Maximization of cardiac stroke volume with fluid infusion

Maximization of cardiac stroke volume with fluid infusion

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Morten Bundgaard-Nielsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of anesthesiology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RCT_PROST_ORTO

Identifier Type: -

Identifier Source: org_study_id