High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery (HICOSIRS)
A high cut off dialyzer (septeX) is tested in patients after cardio-thoracic surgery with incidence of "systemic inflammatory response syndrome" (SIRS) and associated increased risk for acute kidney injury (AKI). Hypothesis: The high cut off dialyzer (septeX) can increase the postoperative IL-6/Il-10 ratio.
Systemic Inflammatory Response Syndrome
Acute Kidney Injury
Other: standard therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effects of High-cutoff (HCO) Hemofiltration in the Immediate Postoperative Period on Systemic Inflammatory Response Syndrome (SIRS) and Renal Recovery in Cardiac Surgery Patients With a High Risk for Renal Failure. (HICOSIRS)|
- IL6/IL10 ratio [ Time Frame: Change from Baseline in IL6/IL10 ratio at 48h post cardiac surgery and last day at hospital (expected average of 2 weeks after cardiac surgery) ] [ Designated as safety issue: No ]To test, if immediate postoperative HCO-CVVH reduces systemic inflammation (determined as the ratio between Il-6 / Il-10) in patients with a high risk for CSA-AKI in comparison with a treatment without early RRT. To calibrate for differences in baseline cytokine levels and with respect to the high variability of cytokines in the postoperative period the area-under-the-curve (AUC) of the postoperative increase in the IL-6/Il-10 ratio until 48h will be used.
- determination of immediate postoperative HCO-CVVH improvement [ Time Frame: 6 month post cardiac surgery ] [ Designated as safety issue: No ]
- Short- and medium term recovery of renal function
- time to extubation
- cardiac function
- need for vasoactive and inotropic drugs
- duration of treatment in a high-dependency unit
- Laboratory assessments [ Time Frame: 48h after cardiac surgery and last day at hospital (expected average 2 weeks) ] [ Designated as safety issue: No ]
- urinary fatty acid binding protein (U-FABP)
- association of Human placental growth factor (PIGF) and Soluble fms-like tyrosine kinase (S-flt-1)
- adverse effects [ Time Frame: 48h after cardiac surgery ] [ Designated as safety issue: Yes ]To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
septeX CVVH for 12h after cardiac surgery
12 h septeX CVVH treatment after cardiac surgery
Other Name: high cut off
standard therapy according to local practice
Other: standard therapy
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
Cardiac surgery associated systemic inflammatory response syndrome (SIRS) plays an important pathophysiological role in the development of AKI in patients after cardiothoracic surgery.
Previous studies have shown that the elimination of inflammatory mediators can be either achieved by Continuous Venous Venous Hemodialysis(CVVHD) or Continuous Venous Venous Hemofiltration (CVVH) by using a high-cutoff (HCO) membrane with a cut-off 45kD. Data from patients treated with HCO-CVVHD during septic shock show a reduction in systemic cytokines and improved hemodynamics.
No data about the effects of early HCO-CVVH in cardiac surgery patients with a high risk of Cardiac Surgery associated AKI and consequently a high rate of postoperative renal replacement therapy (RRT) are available.
It is of note that patients with Euroscore > 6 are on high risk to develop SIRS associated AKI.
No pharmacological anti-inflammatory approach has convincingly shown to prevent renal dysfunction in these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579396
|Klinik für Anaesthesiologie UKSH Luebeck|
|Luebeck, Schleswig-Holstein, Germany, 23538|
|Principal Investigator:||Matthias Heringlake, Prof. Dr.||Universitaet zu Luebeck|