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

NCT01276665 | Completed

• 1 other identifier: 154/08
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer; Urinary Diversion

Keywords

Bladder cancer; urinary diversion; Postoperative Complications; Fluid Therapy; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• Complications (morbidity score)

  during hospitalisation, at 30 days postoperative

Secondary Outcomes (3)

• Perioperative blood loss and quality of the surgical field

  intraoperative

• -Hospital stay

  hospital discharge

• Correlation between pelvic venous pressure and bleeding

  intraoperative

Study Arms (2)

Restrictive regimen group

EXPERIMENTAL

treated with a restrictive fluid regimen of 2ml/kg/h of crystalloids in combination with sympathicomimetics.

Procedure: restrictive intraoperative fluid substitution

Control group

ACTIVE COMPARATOR

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

Interventions

restrictive intraoperative fluid substitution PROCEDURE

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

Restrictive regimen group

assessment of the pelvic venous pressure PROCEDURE

A 20 G catheter will be introduced into a small collateral vein of the internal iliacal vein to monitor pelvic venous pressure

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• ASA 1 to 3
• Radical cystectomy with ileal neobladder/ileum conduit

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Anesthesiology and Pain Therapy, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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. doi: 10.1097/00000542-200507000-00008.

  PMID: 15983453 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Y Wuethrich, MD

  Dep. of Anesthesiology and Pain Therapy, University Hospital Beern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 13, 2011
• Study Start: November 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

CH (1)