Clinical trial NCT01035541: Goal Directed Hemodynamic Management and Renal Outcome After Major Non-cardiac Surgery
Official title: Can Goal Directed Hemodynamic Management Improve Renal Outcome After Major Non-cardiac Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Non-cardiac Surgery
Keywords: Major non-cardiac surgery,
hemodynamic management,
PiCCO,
acute kidney injury,
renal outcome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients udndergoing Major non-cardiac surgery

Brief 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.

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 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

Primary outcomes:
measure: maximum change in serum creatinine within 3 days
timeFrame: Start of anesthesia until third postoperative day (72 hours)
Secondary outcomes:
measure: incidence of AKI according to the RIFLE criteria, need for dialysis, pulmonal complications, rate of anastomotic insufficiency, sepsis, reoperation
timeFrame: 1 year
Other outcomes:
Locations:
city: Munic
country: Germany
facility: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München
name: Bettina Jungwirth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.