Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Perioperative Outcome in Patients Undergoing Radical Cystectomy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bladder Cancer Urinary Diversion |
Procedure: restrictive intraoperative fluid substitution Procedure: assessment of the pelvic venous pressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Blood Loss and Perioperative Outcome in Patients Undergoing Open Radical Cystectomy |
- Complications (morbidity score) [ Time Frame: during hospitalisation, at 30 days postoperative ] [ Designated as safety issue: Yes ]
- Perioperative blood loss and quality of the surgical field [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
- -Hospital stay [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
- Correlation between pelvic venous pressure and bleeding [ Time Frame: intraoperative ] [ Designated as safety issue: Yes ]
| Enrollment: | 190 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Restrictive regimen group
treated with a restrictive fluid regimen of 2ml/kg/h of crystalloids in combination with sympathicomimetics.
|
Procedure: restrictive intraoperative fluid substitution
to analyze the impact of a restrictive volume regimen using advanced balanced electrolyte solution (which is by far more restrictive than the published data) combined with noradrenaline. We include only radical cystectomy and so nearly exclude surgical bias
|
|
Active Comparator: Control group
treated according to an internationally accepted standard fluid regimen (6 ml/kg/h of crystalloids and correction of the hypotony with fluid boluses)
|
Procedure: assessment of the pelvic venous pressure
A 20 G catheter will be introduced into a small collateral vein of the internal iliacal vein to monitor pelvic venous pressure
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Switzerland | |
| Dep. of Anesthesiology and Pain Therapy, Bern University Hospital | |
| Bern, Switzerland, 3010 | |
| Principal Investigator: | Patrick Y Wuethrich, MD | Dep. of Anesthesiology and Pain Therapy, University Hospital Beern, Switzerland |
More Information
Publications:
| Responsible Party: | Dr Patrick Wüthrich/Department of Anesthesiology and Pain Therapy, University Hospital Bern |
| ClinicalTrials.gov Identifier: | NCT01276665 History of Changes |
| Other Study ID Numbers: | 154/08 |
| Study First Received: | January 12, 2011 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Switzerland: Independent Local Research Ethic Commission (Ethikkommission) |
Keywords provided by University Hospital Inselspital, Berne:
|
Bladder cancer urinary diversion Postoperative Complications Fluid Therapy Norepinephrine |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Norepinephrine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013