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Completed

NCT Number: NCT01035541

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PiCCO® Monitoring

Device

Fluid and vasopressor management according to PiCCO measruements

Primary outcomes

  1. maximum change in serum creatinine within 3 days

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

Secondary outcomes

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

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?

Acronym: IROM

Important dates

Study start
2009
Primary completion
2012
First posted
Dec 18, 2009
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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