Back to resultsStudy Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
Primary Purpose
Kidney Failure, Acute, Shock
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Standard polyamide high flux membrane
High cut-off (super high flux) polyamide membrane
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Acute focused on measuring Kidney failure, acute, Shock, Toxins, biological, Hemofiltration, High cut off/super high flux membranes
Eligibility 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
Sites / Locations
- Austin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
CVVH using standard high flux membrane with standard CVVH settings
Outcomes
Primary Outcome Measures
The primary outcome measure for this study is noradrenaline free time in the first week after randomization
Secondary Outcome Measures
The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00912184
Brief Title
Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
Official Title
Pilot Randomised Controlled Study Comparing The Effect of High Cut-off Point Haemofiltration With Standard Haemofiltration In Patients With Acute Renal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austin Health
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute, Shock
Keywords
Kidney failure, acute, Shock, Toxins, biological, Hemofiltration, High cut off/super high flux membranes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CVVH with high cut-off polyamide membrane (P2SH) using standard continuous veno-venous hemofiltration (CVVH) settings
Arm Title
2
Arm Type
Active Comparator
Arm Description
CVVH using standard high flux membrane with standard CVVH settings
Intervention Type
Device
Intervention Name(s)
Standard polyamide high flux membrane
Other Intervention Name(s)
High flux membrane
Intervention Description
Standard haemofiltration; CVVH; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hr, anticoagulation as clinically indicated, bicarbonate buffered replacement fluid
Intervention Type
Device
Intervention Name(s)
High cut-off (super high flux) polyamide membrane
Other Intervention Name(s)
P2SH, Super high flux membrane
Intervention Description
CVVH with standard haemofiltration settings; blood flow 200 ml/min, ultrafiltrate 25 ml/kg/hour, anticoagulation as clinically indicated, bicarbonate-buffered replacement fluid
Primary Outcome Measure Information:
Title
The primary outcome measure for this study is noradrenaline free time in the first week after randomization
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The change in the levels of each of three key cytokines; IL-1, IL-6 and IL-10
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafidah Atan, MBBS, FANZCA
Organizational Affiliation
Austin Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
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Study Comparing High Cut-off Haemofiltration With Standard Haemofiltration in Acute Renal Failure
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