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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rafidah Atan, Austin Health
ClinicalTrials.gov Identifier:
NCT00912184
First received: June 1, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Acute
Shock
Device: Standard polyamide high flux membrane
Device: High cut-off (super high flux) polyamide membrane
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by Austin Health:

Primary Outcome Measures:
  • The primary outcome measure for this study is noradrenaline free time in the first week after randomization [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: May 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: High flux membrane

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912184

Locations
Australia, Victoria
Austin Hospital
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Austin Health
Investigators
Principal Investigator: Rafidah Atan, MBBS, FANZCA Austin Health
  More Information

Publications:
Hack CE, Aarden LA, Thijs LG: Role of cytokines in sepsis. Adv Immunol 1997; 66:101-195
Dinarello CA: Proinflammatory cytokines. Chest 2000; 118:503-508

Responsible Party: Rafidah Atan, PhD student, Austin Health
ClinicalTrials.gov Identifier: NCT00912184     History of Changes
Other Study ID Numbers: High cut-off trial
Study First Received: June 1, 2009
Last Updated: January 26, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Austin Health:
Kidney failure, acute
Shock
Toxins, biological
Hemofiltration
High cut off/super high flux membranes

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014