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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01579396

Systemic Inflammatory Response Syndrome Acute Kidney Injury

WITHDRAWN NA

Effects of HIgh Volume COntinuous REnal Replacement Therapy in Patients With Septic Acute Kidney Injury

NCT01191905

Sepsis Kidney Failure, Acute Renal Replacement Therapy

COMPLETED NA

Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization

NCT04836026

Pediatric Kidney Disease Acute Kidney Injury

COMPLETED

Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure

NCT01072682

Acute Renal Failure

COMPLETED NA

Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy

NCT03078504

Acute Kidney Injury End-stage Renal Disease

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Inflammatory Response Syndrome Kidney Failure, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HCO

High cut-off filters HCO1100

Group Type EXPERIMENTAL

continuous venovenous hemodialysis

Intervention Type DEVICE

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.

control

conventional high-flux filters

Group Type ACTIVE_COMPARATOR

continuous venovenous hemodialysis

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No