Acute Kidney Injury, Systemic Inflammatory Response Syndrome
Conditions
Keywords
septeX, high cut-off, Thoracic Surgery, Renal Replacement Therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEsepteX
12 h septeX CVVH treatment after cardiac surgery
OTHERstandard therapy
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
Sponsors
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Scheduled for complex / prolonged cardiac surgery (i.e.combined CABG+ valve surgery, Redo surgery) with an anticipated CPB time \> 120 min * CKD with an e GFR \< 50ml/min/m2 * Euroscore \> 6
Exclusion criteria
* End stage CKD (dialysis dependent) renal failure before surgery * Radiocontrast exposure within 24 hours before surgery * Active endocarditic with antibiotic treatment * pulmonary disease with chronic hypoxia * Clinically significant liver dysfunction (bilirubin \> 1.8mg/dl (30µmol/L)) * Known HIV, HCV infection * Alcoholism * Active uncontrolled infection * Pregnancy or lactation * Inability to give informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IL6/IL10 ratio | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory assessments | 48h after cardiac surgery and last day at hospital (expected average 2 weeks) | * 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) |
| adverse effects | 48h after cardiac surgery | To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT. |
| determination of immediate postoperative HCO-CVVH improvement | 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 |
Countries
Germany
Outcome results
None listed