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

Not Applicable

Withdrawn

• Conditions: Systemic Inflammatory Response Syndrome; Acute Kidney Injury
• Interventions: Other: standard therapy; Device: septeX

• Registration Number: NCT01579396
• Lead Sponsor: Vantive Health LLC

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.

Study Timeline

• Study First Submitted: 2012-01-18
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard therapy	standard therapy	standard therapy according to local practice
septeX	septeX	septeX CVVH for 12h after cardiac surgery

Primary Outcome Measures

Name	Time	Method
IL6/IL10 ratio	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)	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

Name	Time	Method
adverse effects	48h after cardiac surgery	To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.
determination of immediate postoperative HCO-CVVH improvement	6 month post cardiac surgery	* 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	48h after cardiac surgery and last day at hospital (expected average 2 weeks)	* 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)

Trial Locations

Locations (1)

Klinik für Anaesthesiologie UKSH Luebeck; 🇩🇪 Luebeck, Schleswig-Holstein, Germany