High Cut Off Dialysis in Systemic Inflammatory Response Syndrome Patients After Cardiac Surgery (HICOSIRS)
This study is currently recruiting participants.
Verified November 2012 by Gambro Dialysatoren GmbH
Sponsor:
Gambro Dialysatoren GmbH
Information provided by (Responsible Party):
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT01579396
First received: January 18, 2012
Last updated: November 13, 2012
Last verified: November 2012
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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.
| Estimated Enrollment: | 70 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579396
Contacts
| Contact: Torsten Boehler, Dr. | +49(0)1752913578 | torsten.boehler@gambro.com |
| Contact: Kristin Werner, Msc | +49(0)7471172024 | kristin.werner@gambro.com |
Locations
| Germany | |
| Klinik für Anaesthesiologie UKSH Luebeck | Recruiting |
| Luebeck, Schleswig-Holstein, Germany, 23538 | |
| Contact: Matthias Heringlake, MD +49(0)451 / 500- 2772 Heringlake@t-online.de | |
| Contact: Julika Schoen, MD + 49 (0) 451 500-2773 Julika.Schoen@uk-sh.de | |
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: | November 13, 2012 |
| 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 Systemic Inflammatory Response Syndrome Renal Insufficiency Kidney Diseases |
Urologic Diseases Inflammation Pathologic Processes Shock |
ClinicalTrials.gov processed this record on May 23, 2013