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

Major Non-cardiac Surgery Clinical Trial

— IROM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035541
• Other study ID #: IROM
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: January 16, 2013
• Start date: December 2009

Study information

• Verified date: January 2013
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Major Non-cardiac Surgery

Intervention

Device:
• PiCCO® Monitoring
Fluid and vasopressor management according to PiCCO measruements

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Epub 2006 Nov 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum change in serum creatinine within 3 days		Start of anesthesia until third postoperative day (72 hours)
Secondary	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