Skip to main content
OpenTrials
Completed

NCT Number: NCT00912184

Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard polyamide high flux membrane

Device

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

High cut-off (super high flux) polyamide membrane

Device

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

Primary outcomes

  1. The primary outcome measure for this study is noradrenaline free time in the first week after randomization

    Time frame: 24 months

Secondary outcomes

  1. The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 3, 2009
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.