Radical Prostatectomy and Perioperative Fluid Therapy

Prostate Cancer Clinical Trial

Official title:

Radical Prostatectomy and Perioperative Fluid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771966
• Other study ID #: RCT_PROST_ORTO
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2008
• Last updated: October 19, 2012
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• Standard therapy
Standard therapy
• Maximization of cardiac stroke volume with fluid infusion
Maximization of cardiac stroke volume with fluid infusion

Locations

Country	Name	City	State
Denmark	Dept of anesthesiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate		6 hours	No
Secondary	Investigate intraoperative haemodynamics		Intraoperative	No