Super High-Flux - High Volume Dialysis in Sepsis-Induced Acute Renal Failure

NCT00333593 | Completed Phase 1

• 1 other identifier: H2003/01440
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients within the intensive care unit who have severe infections causing shock and kidney failure have almost a 60% risk of dying despite antibiotic therapy, surgical drainage of the site of infection and intensive care support with fluids, nutrition, mechanical ventilation and continuous artificial kidney support. This persistently high death rate continues to stimulate the development of new approaches to the treatment of septic shock. Much clinical and molecular biology research suggests that these patients die because of an uncontrolled immune system's response to infection. This response involves the production of several substances (so called "humoral mediators"), which enter the blood stream and affect the patient's organs ability to function and the patient's ability to kill germs. These substances may potentially be removed by new artificial filters similar to those currently used during continuous hemofiltration (the type of artificial kidney support used in intensive care). Recent investigations by ourselves and others, however, have made the following findings:

1. 1.Standard filters currently used in intensive care are ineffective in removing large amounts of these "humoral mediators" because the holes in the filter are too small to allow all of them to pass through
2. 2.The standard filters currently used in intensive care are also ineffective in removing large amounts of these "humoral mediators" because the standard filtration flow through the membrane is less than 100 ml/min
3. 3.When the filtration flow through the membrane is increased to above 100ml/min, patients require a lesser dose of drugs to support their blood pressure which is an indirect sign that the filters are clearing some of the "humoral mediators"
4. 4.Even when the blood flow through standard filters is increased to above 100ml/min, there is still not optimal clearing of "humoral mediators" It is possible, however, that, using a different filter membrane with bigger holes in it, would make it easier to clear the blood of these "humoral mediators". It is thought that this would be noticeable clinically in the amount of drugs required to support blood pressure.

Conditions

Sepsis; Acute Renal Failure

Keywords

Dialysis; Large pore dialyser; Cytokines; Noradrenaline

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure for this study is the relative change in plasma IL-6 levels.

Secondary Outcomes (3)

• The secondary outcome is the clearance and the absolute change in the levels of IL-6 and other cytokines.

• The other secondary outcome is the change in noradrenaline dose required to maintain baseline mean blood pressure (typically 70 mmHg)

• change in the levels of other cytokines.

Interventions

Large pore dialyser DEVICE

Standard dialyser DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who fulfil the consensus criteria for sepsis (21) and recently proposed criteria for severe ARF (1) are eligible for the study.

You may not qualify if:

• Patients under 18 years of age.
• Patients who are pregnant or breastfeeding
• Patients with a known allergy to polyamide
• Patients expected to die within 24 hours
• Patients in whom there are limitations on the intensity of therapy

Sponsors & Collaborators

• Austin Health: lead

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3084, Australia

Location

Related Publications (2)

• Haase M, Bellomo R, Baldwin I, Haase-Fielitz A, Fealy N, Davenport P, Morgera S, Goehl H, Storr M, Boyce N, Neumayer HH. Hemodialysis membrane with a high-molecular-weight cutoff and cytokine levels in sepsis complicated by acute renal failure: a phase 1 randomized trial. Am J Kidney Dis. 2007 Aug;50(2):296-304. doi: 10.1053/j.ajkd.2007.05.003.

  PMID: 17660031 DERIVED

• Haase M, Bellomo R, Baldwin I, Haase-Fielitz A, Fealy N, Morgera S, Goehl H, Storr M, Boyce N, Neumayer HH. Beta2-microglobulin removal and plasma albumin levels with high cut-off hemodialysis. Int J Artif Organs. 2007 May;30(5):385-92. doi: 10.1177/039139880703000505.

  PMID: 17551901 DERIVED

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rinaldo Bellomo, MD, FRACP

  Austin Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 5, 2006
• First Posted: June 6, 2006
• Study Start: June 1, 2006
• Study Completion: November 1, 2006
• Last Updated: December 27, 2006

Record last verified: 2006-12

Locations

AU (1)