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

Acute Kidney Injury Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01579396
• Other study ID #: 1486
• Status: Withdrawn
• Phase: N/A
• First received: January 18, 2012
• Last updated: April 4, 2017
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

Device:
• septeX
12 h septeX CVVH treatment after cardiac surgery

Other:
• standard therapy
standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)

Locations

Country	Name	City	State
Germany	Klinik für Anaesthesiologie UKSH Luebeck	Luebeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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	6 month post cardiac surgery
Secondary	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)	48h after cardiac surgery and last day at hospital (expected average 2 weeks)
Secondary	adverse effects	To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.	48h after cardiac surgery