Radical Prostatectomy and Perioperative Fluid Therapy

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00771966

RCT_PROST_ORTO

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Standard treatment

Placebo Comparator group

Treatment:

Procedure: Standard therapy

SV maximization

Active Comparator group

Treatment:

Procedure: Maximization of cardiac stroke volume with fluid infusion