Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery

Completed

• Conditions: Major Non-cardiac Surgery
• Interventions: Device: PiCCO® Monitoring

• Registration Number: NCT01035541
• Lead Sponsor: Technical University of Munich

Brief Summary

This study is designed to compare renal outcome of patients following major non-cardiac surgery with different perioperative hemodynamic managements: a goal directed hemodynamic management group (using PiCCO) and a control group.

Detailed Description

Acute kidney injury (AKI) is a common complication after major surgery. Many studies showed that AKI is associated with different complications: higher mortality, renal replacement therapy and prolonged hospital stay resulting in higher health care costs.

Until now just a few studies are published on prevention or therapy of AKI after major surgery. Most of these investigations are underpowered or show just marginal benefit. There are no studies published investigating the impact of goal-directed hemodynamic management on renal outcome following non-cardiac major surgery, even though hemodynamic stability seems to be of paramount importance for the kidneys.

Aim of this study is to investigate the impact of a goal directed hemodynamic management on renal outcome after major non-cardiac surgery.

Therefore patients will be randomized in one of two groups, the PiCCO group with goal directed hemodynamic management and the Control group, where PICCO data will be collected but will not influence hemodynamic management. In both groups the monitoring with transpulmonary thermodilution will be continued in the intensive care unit until 72 hours after surgery.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Elective major non-cardiac surgery lasting more than 3 hours with a following intensive care unit stay for more than 3 days:

  • gastrectomy
  • pancreas surgery
  • small bowel surgery
  • esophageal surgery

• Age ≥ 18 years

• ASA classification I to III

• Written informed consent

Exclusion Criteria

• Need for dialysis

• Contraindications for an arterial line in the femoral artery:

  • stents
  • bypasses
  • severe peripheral artery occlusive disease

• ASA classification IV to V

• Pregnant Woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C group	PiCCO® Monitoring	Conventional fluid management
P group	PiCCO® Monitoring	Fluid Management according to measurements with PiCCO®

Primary Outcome Measures

Name	Time	Method
maximum change in serum creatinine within 3 days	Start of anesthesia until third postoperative day (72 hours)

Secondary Outcome Measures

Name	Time	Method
incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation	1 year	All points are additionnally registered one year after the operation via telephone-questionnaire of the patient and his general practitioner

Trial Locations

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munic, Bavaria, Germany