- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875888
High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock (HICOSS)
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
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Having signs of renal dysfunction
- Requirement for catecholamine administration (norepinephrine or others)
- 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:
- Lack of written informed consent from patients or a legally authorized surrogate
- Duration of septic shock greater than 4 days
- Hypoproteinemia (characterized by serum albumin less than 18 g/l)
- End stage renal failure
- Known active malignancy
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Age younger than 18 years or older than 80 years
- Known pregnancy
- Immunosuppression after transplantation
- Participation in another clinical study
- Renal replacement therapy greater than 24 hours before randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HCO
High cut-off filters HCO1100
|
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.
|
ACTIVE_COMPARATOR: control
conventional high-flux filters
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dosage of vasopressors
Time Frame: day 1 to day 5
|
day 1 to day 5
|
Mean arterial pressure
Time Frame: day before inclusion and day 1 to day 5
|
day before inclusion and day 1 to day 5
|
Heart rate
Time Frame: day before inclusion and day 1 to day 5
|
day before inclusion and day 1 to day 5
|
Central venous pressure
Time Frame: day before inclusion and day 1 to day 5
|
day before inclusion and day 1 to day 5
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival
Time Frame: 28 days
|
28 days
|
Sequential organ failure assessment (SOFA) score
Time Frame: at ICU admission, at inclusion and day 1 to day 5
|
at ICU admission, at inclusion and day 1 to day 5
|
Length of need for catecholamine application
Time Frame: 28 days follow up
|
28 days follow up
|
Length of need for mechanical ventilation
Time Frame: 28 days
|
28 days
|
Length of need for renal replacement therapy
Time Frame: 28 days
|
28 days
|
Length of stay in intensive care unit (ICU)
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Werner Beck, Dr., Gambro Dialysatoren GmbH
Publications and helpful links
General Publications
- 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. doi: 10.1097/01.CCM.0000229147.50592.F9.
- Morgera S, Haase M, Rocktaschel J, Bohler T, von Heymann C, Vargas-Hein O, Krausch D, Zuckermann-Becker H, Muller 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. doi: 10.1093/ndt/gfg435.
- Morgera S, Rocktaschel J, Haase M, Lehmann C, von Heymann C, Ziemer S, Priem F, Hocher B, Gohl 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. doi: 10.1007/s00134-003-2003-9. Epub 2003 Sep 3.
- Morgera S, Haase M, Rocktaschel J, Bohler T, Vargas-Hein O, Melzer C, Krausch D, Kox WJ, Baumann G, Beck W, Gohl H, Neumayer HH. Intermittent high-permeability hemofiltration modulates inflammatory response in septic patients with multiorgan failure. Nephron Clin Pract. 2003;94(3):c75-80. doi: 10.1159/000072024.
- Morgera S, Slowinski T, Melzer C, Sobottke V, Vargas-Hein O, Volk T, Zuckermann-Becker H, Wegner B, Muller 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. doi: 10.1053/j.ajkd.2003.11.006.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000050
- ISRCTN77656437
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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