Radical Prostatectomy and Perioperative Fluid Therapy
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 prostate-cancer
Started Oct 2008
Shorter than P25 for phase_4 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 14, 2008
CompletedFirst Posted
Study publicly available on registry
October 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedOctober 22, 2012
October 1, 2012
1 year
October 14, 2008
October 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate orthostatic cardiovascular response and orthostatic intolerance in patients after removal of the prostate
6 hours
Secondary Outcomes (1)
Investigate intraoperative haemodynamics
Intraoperative
Study Arms (2)
Standard treatment
PLACEBO COMPARATORSV maximization
ACTIVE COMPARATORInterventions
Maximization of cardiac stroke volume with fluid infusion
Eligibility Criteria
You may qualify if:
- Patients with cancer in there prostate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of anesthesiology, Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 14, 2008
First Posted
October 15, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
October 22, 2012
Record last verified: 2012-10