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

T

Technical University of Munich

Status

Completed

Conditions

Major Non-cardiac Surgery

Treatments

Device: PiCCO® Monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT01035541
IROM

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 2 patient groups

P group
Description:
Fluid Management according to measurements with PiCCO®
Treatment:
Device: PiCCO® Monitoring
C group
Description:
Conventional fluid management
Treatment:
Device: PiCCO® Monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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