High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock

Systemic Inflammatory Response Syndrome Clinical Trial

— HICOSS  

Official title:

High Cut-off Continuous Venovenous Hemodialysis (CVVHD) to Improve Hemodynamic Stability and Organ Function Scores in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00875888
• Other study ID #: 0000050
• Secondary ID: ISRCTN77656437
• Status: Terminated
• Phase: N/A
• First received: January 9, 2009
• Last updated: March 5, 2018
• Start date: February 2004
• Est. completion date: June 2009

Study information

• Verified date: March 2018
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD leads to a significant improvement of the hemodynamic status (mean arterial pressure, vasopressor requirements) in septic patients in comparison to CVVHD treatment with conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage of vasopressors needed to maintain an adequate organ perfusion.

Description:

Severe sepsis is a devastating disorder that results from a complex host response to insult after infection. Despite advances in intensive care technologies sepsis remains an important and life-threatening problem. Sepsis is the most common cause of death in the intensive care unit.

Local or systemic release of bacteria-derived compounds, leading to the production of proinflammatory cytokines, induce systemic inflammatory reactions in septic patients. Continuous renal replacement therapies (CRRT) such as hemodialysis (CVVHD), hemofiltration (CVVH) or hemodiafiltration (CVVHDF) with conventional high-flux membranes allow to control fluid and electrolyte balance, and to improve the hemodynamic status of the patients. However, conventional high flux membranes have a limited permeability for sepsis-associated mediators with molecular weights in the range of 15.000 to 60.000 Da.

A promising approach to enhance the mediator removal is to use membranes having larger pores and permeability characteristics than those currently used in CRRT.

For that purpose a High Cut-Off (HCO) membrane has been developed and is manufactured by Gambro Research.After demonstrating the safety as well as the cytokine removal effectiveness in a clinical pilot study this study will assess the influence of the HCO treatment on the disease progression in septic patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Fulfilling at least two of the SIRS criteria as defined by the American College of Chest Physicians (ACCP)/Society of Critical Care Medicine (SCCM) Consensus Conference

2. Having signs of renal dysfunction

3. Requirement for catecholamine administration (norepinephrine or others)

4. Acute Physiology And Chronic Health Evaluation (APACHE II) score at enrolment greater than or equal to 19 and less than or equal to 30

Exclusion Criteria:

1. Lack of written informed consent from patients or a legally authorized surrogate

2. Duration of septic shock greater than 4 days

3. Hypoproteinemia (characterized by serum albumin less than 18 g/l)

4. End stage renal failure

5. Known active malignancy

6. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

7. Age younger than 18 years or older than 80 years

8. Known pregnancy

9. Immunosuppression after transplantation

10. Participation in another clinical study

11. Renal replacement therapy greater than 24 hours before randomization

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency
• Shock, Septic
• Syndrome
• Systemic Inflammatory Response Syndrome

Intervention

Device:
• continuous venovenous hemodialysis
dialysate flow rate 35 ml/h/kg. Blood flow rate should be aimed at 200 ml/min, but not less than 150 ml/min. Bicarbonate- or lactate-buffered solutions will be used as dialysis fluids. Study dialyzers will be changed routinely every 24 h or earlier if the filter is obstructed by clotting.

Locations

Country	Name	City	State
Austria	Leopold Franzens Universität Innsbruck	Innsbruck
Germany	Charité-Virchow Klinik	Berlin
Germany	Medizinische Klinik mit Schwerpunkt Nephrologie Charite, Campus Mitte	Berlin
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Dialysatoren GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (5)

Morgera S, Haase M, Kuss T, Vargas-Hein O, Zuckermann-Becker H, Melzer C, Krieg H, Wegner B, Bellomo R, Neumayer HH. Pilot study on the effects of high cutoff hemofiltration on the need for norepinephrine in septic patients with acute renal failure. Crit Care Med. 2006 Aug;34(8):2099-104. — View Citation

Morgera S, Haase M, Rocktäschel J, Böhler T, Vargas-Hein O, Melzer C, Krausch D, Kox WJ, Baumann G, Beck W, Göhl H, Neumayer HH. Intermittent high-permeability hemofiltration modulates inflammatory response in septic patients with multiorgan failure. Nephron Clin Pract. 2003;94(3):c75-80. — View Citation

Morgera S, Haase M, Rocktäschel J, Böhler T, von Heymann C, Vargas-Hein O, Krausch D, Zuckermann-Becker H, Müller JM, Kox WJ, Neumayer HH. High permeability haemofiltration improves peripheral blood mononuclear cell proliferation in septic patients with acute renal failure. Nephrol Dial Transplant. 2003 Dec;18(12):2570-6. — View Citation

Morgera S, Rocktäschel J, Haase M, Lehmann C, von Heymann C, Ziemer S, Priem F, Hocher B, Göhl H, Kox WJ, Buder HW, Neumayer HH. Intermittent high permeability hemofiltration in septic patients with acute renal failure. Intensive Care Med. 2003 Nov;29(11):1989-95. Epub 2003 Sep 3. — View Citation

Morgera S, Slowinski T, Melzer C, Sobottke V, Vargas-Hein O, Volk T, Zuckermann-Becker H, Wegner B, Müller JM, Baumann G, Kox WJ, Bellomo R, Neumayer HH. Renal replacement therapy with high-cutoff hemofilters: Impact of convection and diffusion on cytokine clearances and protein status. Am J Kidney Dis. 2004 Mar;43(3):444-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of vasopressors		day 1 to day 5
Primary	Mean arterial pressure		day before inclusion and day 1 to day 5
Primary	Heart rate		day before inclusion and day 1 to day 5
Primary	Central venous pressure		day before inclusion and day 1 to day 5
Secondary	Sequential organ failure assessment (SOFA) score		at ICU admission, at inclusion and day 1 to day 5
Secondary	Survival		28 days
Secondary	Length of need for catecholamine application		28 days follow up
Secondary	Length of need for mechanical ventilation		28 days
Secondary	Length of need for renal replacement therapy		28 days
Secondary	Length of stay in intensive care unit (ICU)		28 days