Status:
TERMINATED
High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure After Systemic Inflammatory Response Syndrome (SIRS)/Septic Shock
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Conditions:
Systemic Inflammatory Response Syndrome
Kidney Failure, Acute
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 s...
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-threat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00875888
Start Date
February 1 2004
End Date
June 1 2009
Last Update
March 13 2025
Active Locations (4)
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1
Leopold Franzens Universität Innsbruck
Innsbruck, Austria, 6020
2
Medizinische Klinik mit Schwerpunkt Nephrologie Charite, Campus Mitte
Berlin, Germany, 10117
3
Charité-Virchow Klinik
Berlin, Germany, 13353
4
Universitätsklinikum Tübingen
Tübingen, Germany, 72076