Clinical trial · Interventional
Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Perioperative Outcome in Patients Undergoing Radical Cystectomy
Effects of Noradrenaline Administration Combined With Restrictive Intraoperative Fluid Substitution on Blood Loss and Perioperative Outcome in Patients Undergoing Open Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Diversion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of the pelvic venous pressure | Procedure | — | UNRESOLVED |
| restrictive intraoperative fluid substitution | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Restrictive regimen group
- description
- treated with a restrictive fluid regimen of 2ml/kg/h of crystalloids in combination with sympathicomimetics.
- interventionNames
- Procedure: restrictive intraoperative fluid substitution
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- treated according to an internationally accepted standard fluid regimen (6 ml/kg/h of crystalloids and correction of the hypotony with fluid boluses)
- interventionNames
- Procedure: assessment of the pelvic venous pressure
Primary outcomes (1)
- measure
- Complications (morbidity score)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDNisanevich 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