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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01035541
First received: December 17, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Major Non-cardiac Surgery
Device: PiCCO® Monitoring

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • maximum change in serum creatinine within 3 days [ Time Frame: Start of anesthesia until third postoperative day (72 hours) ]

Secondary Outcome Measures:
  • 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


Enrollment: 180
Study Start Date: December 2009
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
P group
Fluid Management according to measurements with PiCCO®
Device: PiCCO® Monitoring
Fluid and vasopressor management according to PiCCO measruements
C group
Conventional fluid management
Device: PiCCO® Monitoring
Fluid and vasopressor management according to PiCCO measruements

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients udndergoing Major non-cardiac surgery

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035541

Locations
Germany
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Bettina Jungwirth, MD Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
  More Information

Publications:
Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01035541     History of Changes
Other Study ID Numbers: IROM
Study First Received: December 17, 2009
Last Updated: January 16, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Major non-cardiac surgery,
hemodynamic management,
PiCCO,
acute kidney injury,
renal outcome

ClinicalTrials.gov processed this record on October 20, 2014