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

Vantive Health LLC

Status: Withdrawn

Conditions: Acute Kidney Injury; Systemic Inflammatory Response Syndrome

Treatments: Other: standard therapy; Device: septeX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579396

1486

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

septeX

Experimental group

Description:

septeX CVVH for 12h after cardiac surgery

Treatment:

Device: septeX

standard therapy

Other group

Description:

standard therapy according to local practice

Treatment:

Other: standard therapy