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

Can Goal Directed Hemodynamic Management Improve 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.

Study Overview

• Status: Completed
• Conditions: Major Non-cardiac Surgery
• Intervention / Treatment: Device: PiCCO® Monitoring

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 Type: Observational
• Enrollment (Actual): 180

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munic, Bavaria, Germany, 81675
      • Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients udndergoing Major non-cardiac surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Technical University of Munich

Publications and helpful links

General Publications

• Goepfert MS, Reuter DA, Akyol D, Lamm P, Kilger E, Goetz AE. Goal-directed fluid management reduces vasopressor and catecholamine use in cardiac surgery patients. Intensive Care Med. 2007 Jan;33(1):96-103. doi: 10.1007/s00134-006-0404-2. Epub 2006 Nov 21.
• Schmid S, Kapfer B, Heim M, Bogdanski R, Anetsberger A, Blobner M, Jungwirth B. Algorithm-guided goal-directed haemodynamic therapy does not improve renal function after major abdominal surgery compared to good standard clinical care: a prospective randomised trial. Crit Care. 2016 Mar 8;20:50. doi: 10.1186/s13054-016-1237-1.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 17, 2009
• First Submitted That Met QC Criteria: December 17, 2009
• First Posted (Estimate): December 18, 2009

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Major non-cardiac surgery,; hemodynamic management,; PiCCO,; acute kidney injury,; renal outcome
• Other Study ID Numbers: IROM