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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Systemic Inflammatory Response Syndrome; Acute Kidney Injury
• Intervention / Treatment: Device: septeX; Other: standard therapy

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23538
      • Klinik für Anaesthesiologie UKSH Luebeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: septeX; septeX CVVH for 12h after cardiac surgery	Device: septeX; 12 h septeX CVVH treatment after cardiac surgery; Other Names: high cut off
Other: standard therapy; standard therapy according to local practice	Other: standard therapy; standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
adverse effects	To determine, if HCO - CVVH has adverse effects in comparison with no immediate RRT.	48h after cardiac surgery

Collaborators and Investigators

• Sponsor: Vantive Health LLC
• Collaborators: Baxter Healthcare Corporation; Gambro Dialysatoren GmbH
• Investigators: Principal Investigator: Matthias Heringlake, Prof. Dr., Universitaet zu Luebeck

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Estimated): September 1, 2013
• Study Completion (Estimated): December 1, 2013

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimated): April 18, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Thoracic Surgery; Renal Replacement Therapy; septeX; high cut-off
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Inflammation; Renal Insufficiency; Shock; Syndrome; Acute Kidney Injury; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 1486