Radical Prostatectomy and Perioperative Fluid Therapy - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00771966

Purpose

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-hypotension.

Condition	Intervention	Phase
Prostate Cancer	Procedure: Cardiac SV maximization Procedure: Standard Treatment	Phase IV

MedlinePlus related topics: Cancer Nausea and Vomiting Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Single Group Assignment
Official Title:	Radical Prostatectomy and Perioperative Fluid Therapy

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigate intraoperative haemodynamics [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2008
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard treatment: Placebo Comparator	Procedure: Standard Treatment
SV maximization: Active Comparator	Procedure: Cardiac SV maximization Cardiac SV maximization

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771966

Locations

Denmark
Adeling for kirurgisk patpfysiologi 4074, Rigshospitalet	Recruiting
Copenhagen, Denmark
Contact: Morten Bundgaard-Nielsen, MD +4551264186 morten.bundgaard-nielsen@rh.hosp.dk
Contact: Rasmus Gamborg Müller, Stud. Med +4523310932 rgmuller@stud.ku.dk
Principal Investigator: Morten Bundgaard-Nielsen, MD

Sponsors and Collaborators

Rigshospitalet, Denmark

More Information

Responsible Party:	Section of surgical pathophysiology ( Morten Bundgaard-Nielsen )
Study ID Numbers:	RCT_PROST_ORTO
Study First Received:	October 14, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00771966
Health Authority:	Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:

patients with cancer in the prostata

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009