High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery (HICOSIRS)
Primary Purpose
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
septeX
standard therapy
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring septeX, high cut-off, Thoracic Surgery, Renal Replacement Therapy
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
Sites / Locations
- Klinik für Anaesthesiologie UKSH Luebeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
septeX
standard therapy
Arm Description
septeX CVVH for 12h after cardiac surgery
standard therapy according to local practice
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
determination of immediate postoperative HCO-CVVH improvement
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
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
To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
Full Information
NCT ID
NCT01579396
First Posted
January 18, 2012
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01579396
Brief Title
High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
Acronym
HICOSIRS
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first patient, due to recruiting problems.
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Acute Kidney Injury
Keywords
septeX, high cut-off, Thoracic Surgery, Renal Replacement Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
septeX
Arm Type
Experimental
Arm Description
septeX CVVH for 12h after cardiac surgery
Arm Title
standard therapy
Arm Type
Other
Arm Description
standard therapy according to local practice
Intervention Type
Device
Intervention Name(s)
septeX
Other Intervention Name(s)
high cut off
Intervention Description
12 h septeX CVVH treatment after cardiac surgery
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
Primary Outcome Measure Information:
Title
IL6/IL10 ratio
Description
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.
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)
Secondary Outcome Measure Information:
Title
determination of immediate postoperative HCO-CVVH improvement
Description
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
Time Frame
6 month post cardiac surgery
Title
Laboratory assessments
Description
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)
Time Frame
48h after cardiac surgery and last day at hospital (expected average 2 weeks)
Title
adverse effects
Description
To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
Time Frame
48h after cardiac surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Heringlake, Prof. Dr.
Organizational Affiliation
Universitaet zu Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Anaesthesiologie UKSH Luebeck
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
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High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery
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