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

Technical University of Munich180 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

180

Conditions

Major Non-cardiac Surgery

Interventions

PiCCO® MonitoringDEVICE

Fluid and vasopressor management according to PiCCO measruements

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

maximum change in serum creatinine within 3 days

Time frame: Start of anesthesia until third postoperative day (72 hours)

Secondary Outcomes

incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation

All points are additionnally registered one year after the operation via telephone-questionnaire of the patient and his general practitioner

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.