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Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.
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| Name | Class |
|---|---|
| Gambro Dialysatoren GmbH | INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| septeX | Experimental | septeX CVVH for 12h after cardiac surgery |
|
| standard therapy | Other | standard therapy according to local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| septeX | Device | 12 h septeX CVVH treatment after cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| determination of immediate postoperative HCO-CVVH improvement |
| 6 month post cardiac surgery |
| Laboratory assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Heringlake, Prof. Dr. | Universitaet zu Luebeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anaesthesiologie UKSH Luebeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard therapy | Other | standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT) |
|
|
| 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. | 48h after cardiac surgery |
| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |