Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure

January 26, 2012 updated by: Rafidah Atan, Austin Health

Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure

This trial aims to study the effect of combining continuous and a new polyamide membrane with larger pores in the treatment of critically ill patients with acute renal failure and low blood pressure (shock) requiring noradrenaline. The investigators wish to compare the clinical effect of this new therapy to that of haemofiltration with a standard membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During acute renal failure, small and middle molecular-weight toxins accumulate. These molecules are difficult to remove by standard haemofiltration. Accordingly, they accumulate and contribute to morbidity in long-term dialysis patients. Molecules such as cytokines have been shown to play a central pathogenic role in critical illness. In critically ill acute renal failure patients, they accumulate in serum and likely contribute to much morbidity (fever, low blood pressure, myocardial dysfunction, renal failure itself etc.) Therefore, the removal of cytokines appears desirable. Although different approaches have been undertaken, all have had limited success due to complexity, limited efficacy or uncertain clinical response [10-15].

It is possible that in using a different and more porous membrane, the removal of cytokines would be much more efficient and that clinical benefits of blood purification would, therefore, be greater.

A membrane of this kind is now available. It is a modification (moderate increase in pore size) of another standard material called polyamide, which has already been used in millions of people for dialysis and haemofiltration. The increased pore size of these new membranes is directed at a more effective removal of middle molecular-weight toxins such as cytokines.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The treating clinician believes that the patient requires haemofiltration for acute renal failure
  • The patient is on noradrenaline infusion for haemodynamic support
  • The patient was commenced on noradrenaline or haemofiltration within the last 12 hours
  • The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with different membranes
  • The treating clinicians anticipate treating the patient with haemofiltration for at least 72 hours
  • Informed consent has been obtained
  • The patient fulfils ONE of the following clinical criteria for initiating haemofiltration:
  • Oliguria (urine output < 100 ml/6 hr) that has been unresponsive to fluid resuscitation measures.
  • Hyperkalemia ([K+] > 6.5 mmol/L)
  • Severe acidemia (pH < 7.2)
  • Urea > 25 mmol/liter
  • Creatinine > 300 mmol/L
  • Clinically significant organ oedema in the setting of ARF (e.g., lung)

Exclusion Criteria:

  • Patient age is < 18 years
  • Death is imminent (< 24 hours)
  • There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol
  • The patient has been treated with haemofiltration or other dialysis previously during the same hospital admission
  • The patient was on maintenance dialysis prior to the current hospitalisation
  • Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study
  • The patient is pregnant or is breastfeeding
  • The patient has previously been enrolled in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
Device: High cut-off (super high flux) polyamide membrane
CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid
Other Names:
  • P2SH
  • Super high flux membrane
Active Comparator: 2
CVVH using standard high flux membrane with standard CVVH settings
Device: Standard polyamide high flux membrane
Standard haemofiltration; CVVH; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hr, anticoagulation as clinically indicated, bicarbonate buffered replacement fluid
Other Names:
  • High flux membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure for this study is noradrenaline free time in the first week after randomization
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austin Health

Investigators

  • Principal Investigator: Rafidah Atan, MBBS, FANZCA, Austin Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • High cut-off trial

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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