Bladder Cancer Clinical Trial
Official title:
Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Blood Loss and Perioperative Outcome in Patients Undergoing Open Radical Cystectomy
Perioperative fluid management in abdominal surgery is a subject of controversy and current
standard fluid therapy is not evidence based. Compensating decreasing blood pressure by
volume substitution is common praxis. Alternatively the fall in blood pressure due to
vasodilatation can be corrected by applying vasoactive agents. A review of the data on the
effect of "high volume" perioperative fluid therapy suggests that overhydration may have
deleterious effects on cardiopulmonary function as well as on recovery of gastrointestinal
motility, tissue oxygenation and wound healing. Restrictive fluid administration in
fast-track surgery led to no differences in all-over recovery after colonic surgery. Based
on our current knowledge, a low volume regimen combined with a noradrenaline perfusor may be
of benefit during open radical cystectomy. It seems of interest and safe to use a
noradrenaline perfusor combined with a low volume regimen during open radical cystectomy.
The low volume regimen, as described in this study protocol, is well established at our
institution, which has a large experience in cystectomy.
The aim of this study is to compare intraoperative blood loss, quality of the surgical
field, metabolic response, pain relief, fatigue score, gastrointestinal function,
cardiovascular, pulmonary, infectious and surgical complications as well as cognitive
function in two groups of patients undergoing radical cystectomy.
The investigators expect a lower complication rate in the restrictive fluid regimen group
and better surgical conditions. This could significantly affect short- and long-term outcome
of patient undergoing major cancer surgery, have an impact on survival and financial
consequences.
Status | Completed |
Enrollment | 190 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written informed consent - ASA 1 to 3 - Radical cystectomy with ileal neobladder/ileum conduit Exclusion Criteria - Coagulopathies - - Significant hepatic dysfunction (liver enzymes > 50% upper normal value) - - Significant renal dysfunction: GFR< 60 ml/min/1,73 m² (Kidney Disease Outcomes Quality Initiative stade 3 or more ) - Congestive heart failure - Oesophageal pathology - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Anesthesiology and Pain Therapy, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complications (morbidity score) | during hospitalisation, at 30 days postoperative | Yes | |
Secondary | Perioperative blood loss and quality of the surgical field | intraoperative | Yes | |
Secondary | -Hospital stay | hospital discharge | Yes | |
Secondary | Correlation between pelvic venous pressure and bleeding | intraoperative | Yes |
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