High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery (HICOSIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579396
Recruitment Status : Withdrawn (Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.)
First Posted : April 18, 2012
Last Update Posted : April 5, 2017
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Baxter Healthcare Corporation

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.

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Acute Kidney Injury Device: septeX Other: standard therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: septeX
septeX CVVH for 12h after cardiac surgery
Device: septeX
12 h septeX CVVH treatment after cardiac surgery
Other Name: high cut off

standard therapy
standard therapy according to local practice
Other: standard therapy
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)

Primary Outcome Measures :
  1. IL6/IL10 ratio [ 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) ]
    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 Outcome Measures :
  1. determination of immediate postoperative HCO-CVVH improvement [ Time Frame: 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

  2. Laboratory assessments [ Time Frame: 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)

  3. adverse effects [ Time Frame: 48h after cardiac surgery ]
    To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01579396

Klinik für Anaesthesiologie UKSH Luebeck
Luebeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Dialysatoren GmbH
Principal Investigator: Matthias Heringlake, Prof. Dr. Universitaet zu Luebeck

Responsible Party: Baxter Healthcare Corporation Identifier: NCT01579396     History of Changes
Other Study ID Numbers: 1486
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
high cut-off
Thoracic Surgery
Renal Replacement Therapy

Additional relevant MeSH terms:
Acute Kidney Injury
Systemic Inflammatory Response Syndrome
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases