Clinical trial NCT01579396: High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome
Acute Kidney Injury
Keywords: septeX
high cut-off
Thoracic Surgery
Renal Replacement Therapy
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Gambro Dialysatoren GmbH
name: Baxter Healthcare Corporation
First posted: 2012-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: IL6/IL10 ratio
timeFrame: 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 outcomes:
measure: determination of immediate postoperative HCO-CVVH improvement
timeFrame: 6 month post cardiac surgery
measure: Laboratory assessments
timeFrame: 48h after cardiac surgery and last day at hospital (expected average 2 weeks)
measure: adverse effects
timeFrame: 48h after cardiac surgery
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Klinik für Anaesthesiologie UKSH Luebeck
state: Schleswig-Holstein
Study officials:
affiliation: Universitaet zu Luebeck
name: Matthias Heringlake, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: