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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Systemic Inflammatory Response Syndrome
Acute Kidney Injury
Device: septeX
Other: standard therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579396

Locations
Germany
Klinik für Anaesthesiologie UKSH Luebeck
Luebeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
Gambro Dialysatoren GmbH
Investigators
Principal Investigator: Matthias Heringlake, Prof. Dr. Universitaet zu Luebeck
  More Information

No publications provided

Responsible Party: Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier: NCT01579396     History of Changes
Other Study ID Numbers: 1486
Study First Received: January 18, 2012
Last Updated: July 8, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:
septeX
high cut-off
Thoracic Surgery
Renal Replacement Therapy

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

ClinicalTrials.gov processed this record on November 20, 2014