An interventional study of septeX and standard therapy in Systemic Inflammatory Response Syndrome and Acute Kidney Injury, sponsored by Vantive Health LLC. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Vantive Health LLC · Not applicable, Interventional, and Treatment
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.
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
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Exclusion Criteria:
septeX CVVH for 12h after cardiac surgery
Device: septeX
standard therapy according to local practice
Other: standard therapy
12 h septeX CVVH treatment after cardiac surgery
Also known as: high cut off
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
IL6/IL10 ratio
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.
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)
determination of immediate postoperative HCO-CVVH improvement
* 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
Time frame: 6 month post cardiac surgery
Laboratory assessments
* GDF-15 * urinary fatty acid binding protein (U-FABP) * association of Human placental growth factor (PIGF) and Soluble fms-like tyrosine kinase (S-flt-1)
Time frame: 48h after cardiac surgery and last day at hospital (expected average 2 weeks)
adverse effects
To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
Time frame: 48h after cardiac surgery
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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