Radical Prostatectomy and Perioperative Fluid Therapy | NCT00771966

Studies
Radical Prostatectomy and Perioperative Fluid Therapy

NCT00771966

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 22, 2012Estimated

Enrollment

44Actual

Phase

Phase 4

Conditions

Prostate Cancer

Interventions

Standard therapy
Maximization of cardiac stroke volume with fluid infusion

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 14, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2012

Last Update Posted Date

Oct 22, 2012Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard treatment	Placebo Comparator		Procedure: Standard therapy
SV maximization	Active Comparator		Procedure: Maximization of cardiac stroke volume with fluid infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard therapy	Procedure	Standard therapy	Standard treatment
Maximization of cardiac stroke volume with fluid infusion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Investigate intraoperative haemodynamics		Intraoperative

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of anesthesiology, Rigshospitalet		Copenhagen			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided