Acute Kidney Injury Clinical Trial
— HICOSIRSOfficial 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)
Verified date | April 2017 |
Source | Baxter Healthcare Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Anaesthesiologie UKSH Luebeck | Luebeck | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation | Gambro Dialysatoren GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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) | |
Secondary | 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 |
6 month post cardiac surgery | |
Secondary | 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) |
48h after cardiac surgery and last day at hospital (expected average 2 weeks) | |
Secondary | adverse effects | To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT. | 48h after cardiac surgery |
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