NCT01579396

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

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Inflammatory Response Syndrome
• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	septeX	12 h septeX CVVH treatment after cardiac surgery
OTHER	standard therapy	standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2012-04-18
• Last updated: 2025-03-13

Locations

1 site across 1 country: Germany