We wish to compare the effect of using new large hole filters with hemodialysis in patients with severe infections and acute kidney failure to that of standard filters. The new therapy will be considered to be effective if it lowers the amount of drugs used to support blood pressure and if it lowers the blood levels of some “humoral mediators” more than standard therapy. We will also monitor blood levels of important components of blood such as albumin and electrolytes in each group.

Official Title

Randomized, Cross Over Study Comparing Standard Hemodialysis to Hemodialysis With a Novel Polyamide Membrane (P2SH) in Patients With Sepsis and Acute Renal Failure

Conditions

Acute Renal Failure, Sepsis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

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

Secondary Outcome Measures:

  • 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.

Study Start

June 2006; Study completion: November 2006

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • All patients who fulfil the consensus criteria for sepsis (2) and recently proposed criteria for severe ARF (1) are eligible for the study.

Exclusion Criteria:

  • 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

References

  1. Bellomo R, Ronco C, Kellum JA. Acute renal failure: time for consensus. Intensive Care Med 2001; 27: 1685-1688
  2. The ACCP/SCCM Consensus conference committee: Bone RC, Balk RA, Cerra FB, Dellinger RP,Fein AM, Knaus WA, Schein RMH, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest 1992; 101:1644-55.

Total Enrolment

10

Contact Details

Austin Hospital, Melbourne, Victoria, 3084, Australia

  • Rinaldo Bellomo, MD, FRACP, Principal Investigator, Austin Health