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

This study has been withdrawn prior to enrollment.
(Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.)
Sponsor:
Information provided by (Responsible Party):
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT01579396
First received: January 18, 2012
Last updated: July 8, 2013
Last verified: July 2013

January 18, 2012
July 8, 2013
April 2012
September 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01579396 on ClinicalTrials.gov Archive Site
  • determination of immediate postoperative HCO-CVVH improvement [ Time Frame: 6 month post cardiac surgery ] [ Designated as safety issue: No ]
    • 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
  • Laboratory assessments [ Time Frame: 48h after cardiac surgery and last day at hospital (expected average 2 weeks) ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 48h after cardiac surgery ] [ Designated as safety issue: Yes ]
    To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
Same as current
Not Provided
Not Provided
 
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
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)

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Inflammatory Response Syndrome
  • Acute Kidney Injury
  • Device: septeX
    12 h septeX CVVH treatment after cardiac surgery
    Other Name: high cut off
  • Other: standard therapy
    standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
  • Experimental: septeX
    septeX CVVH for 12h after cardiac surgery
    Intervention: Device: septeX
  • standard therapy
    standard therapy according to local practice
    Intervention: Other: standard therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01579396
1486
No
Gambro Dialysatoren GmbH
Gambro Dialysatoren GmbH
Not Provided
Principal Investigator: Matthias Heringlake, Prof. Dr. Universitaet zu Luebeck
Gambro Dialysatoren GmbH
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP