Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Perioperative Outcome in Patients Undergoing Radical Cystectomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01276665
First received: January 12, 2011
Last updated: December 17, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Complications (morbidity score) [ Time Frame: during hospitalisation, at 30 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276665

Locations
Switzerland
Dep. of Anesthesiology and Pain Therapy, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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 April 17, 2014