High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery (HICOSIRS)
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|ClinicalTrials.gov Identifier: NCT01579396|
Recruitment Status : Withdrawn (Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.)
First Posted : April 18, 2012
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Systemic Inflammatory Response Syndrome Acute Kidney Injury||Device: septeX Other: standard therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||December 2013|
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)
- 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) ]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 ]
- 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) ]
- 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 ]To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579396
|Klinik für Anaesthesiologie UKSH Luebeck|
|Luebeck, Schleswig-Holstein, Germany, 23538|
|Principal Investigator:||Matthias Heringlake, Prof. Dr.||Universitaet zu Luebeck|