Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000652976
Ethics application status
Approved
Date submitted
24/06/2011
Date registered
24/06/2011
Date last updated
2/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
To investigate patient's outcome using different hemofilter materials in those with sepsis associated acute renal failure
Scientific title
The effect of PMMA versus PS membrane on mortality in patients with septic acute kidney injury receiving continuous venovenous hemofiltration
Secondary ID [1] 262462 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis 268151 0
Acute kidney injury 268152 0
Condition category
Condition code
Renal and Urogenital 268286 268286 0 0
Kidney disease
Infection 268294 268294 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Citrate continuous venovenous hemofiltration using Polymethylmethacrylate (PMMA) membrane hemofilter during acute kidney injury period until death or discharge from ICU
Intervention code [1] 266821 0
Treatment: Devices
Comparator / control treatment
Citrate continuous venovenous hemofiltration using Polysulfone (PS) membrane hemofilter during acute kidney injury period until death or discharge from ICU
Control group
Active

Outcomes
Primary outcome [1] 269018 0
Mortality
Timepoint [1] 269018 0
28 days
Secondary outcome [1] 276827 0
Sequential Organ Failure Assessment (SOFA) score
Timepoint [1] 276827 0
Daily until death or discharge from ICU
Secondary outcome [2] 276828 0
Best mean arterial pressure (MAP)
Timepoint [2] 276828 0
Daily until death or discharge from ICU
Secondary outcome [3] 276829 0
Vasopressor dosage
Timepoint [3] 276829 0
Daily until death or discharge from ICU
Secondary outcome [4] 276830 0
Best Oxygenation (PaO2/FiO2 ratio) based on arterial blood gas results and oxygen concentration provided via oxygen cannula or ventilator
Timepoint [4] 276830 0
Daily until death or discharge from ICU
Secondary outcome [5] 276831 0
Urine output based on all urinary catheter output charting
Timepoint [5] 276831 0
Daily until death or discharge from ICU
Secondary outcome [6] 276832 0
Length of stay in intensive care unit (ICU)
Timepoint [6] 276832 0
ICU discharge time
Secondary outcome [7] 276833 0
Length of stay in hospital
Timepoint [7] 276833 0
Hospital discharge time

Eligibility
Key inclusion criteria
1. Severe sepsis (defined based on ACCP/ SCCM criteria, ie Systemic Inflammatory Response Syndrome in the presence of suspected or known infection, leading to organ dysfunction), and
2. Acute kidney injury (defined based on RIFLE criteria, “Injury” grade or above, who required continuous venovenous hemofiltration support)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication for regional citrate anticoagulation (Liver failure or cirrhosis with impaired citrate metabolism, allergy to citrate)
2. Pregnancy
3. Terminal illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Eligible patients should fulfill all the inclusion criteria and without any exclusion criteria
2. Obtain consent from patient directly. For those with impaired consciousness due to underlying illness, consent should be obtained from their close relatives
3. Randomization by computer generated scheme
4. Allocation concealment by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by computer generated scheme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/08/2011
Actual
17/05/2012
Date of last participant enrolment
Anticipated
30/04/2017
Actual
30/04/2017
Date of last data collection
Anticipated
Actual
30/06/2017
Sample size
Target
120
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 3644 0
Hong Kong
State/province [1] 3644 0

Funding & Sponsors
Funding source category [1] 267295 0
Hospital
Name [1] 267295 0
Pamela Youde Nethersole Eastern Hospital
Country [1] 267295 0
Hong Kong
Primary sponsor type
Hospital
Name
Department of intensive care, Pamela Youde Nethersole Eastern Hospital
Address
3 Lok Man Road
Chai Wan
Country
Hong Kong
Secondary sponsor category [1] 266363 0
None
Name [1] 266363 0
Address [1] 266363 0
Country [1] 266363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269289 0
Hong Kong East Cluster ethics committee
Ethics committee address [1] 269289 0
3 Lok Man Road
Chai Wan
Ethics committee country [1] 269289 0
Hong Kong
Date submitted for ethics approval [1] 269289 0
Approval date [1] 269289 0
20/06/2011
Ethics approval number [1] 269289 0
HKEC-2011-032

Summary
Brief summary
Acute kidney injury (AKI) affects 5% to 7% of all hospitalized patients. Sepsis and septic shock remain the most important cause of AKI in critically ill patients and account for more than 50% of cases of AKI in the intensive care unit. The Acute Dialysis Quality Initiative has developed a consensus definition of AKI that uses the acronym RIFLE (Risk, Injury, Failure, Loss and End stage). Septic AKI is AKI occurring in the simultaneous presence of both the RIFLE criteria for AKI and the consensus criteria for sepsis, in the absence of other clear and established, non–sepsis-related (e.g., radiocontrast, other nephrotoxins) cause of AKI.
It is widely accepted that cytokines play an important role in the pathogenesis of sepsis and septic shock. Cytokines removal by varies blood purification techniques like high volume hemofiltration and plasmaphresis may be useful in these situations. Polymethylmethacrylate (PMMA) membrane hemofilter remove cytokines from blood mainly by adsorption to membrane matrix of the hemofilter. This special membrane characteristic is absence in Polyacrylonitrate (PAN) or Polysulfone (PS) membrane hemofilter commonly used for continuous renal replacement therapy (CRRT). Studies showed that using PMMA based CRRT in patient with septic AKI may associate with early improvement of hemodynamics, oxygenation and improvement of urine output. When compared with PAN based CRRT, patients treated with PMMA based CRRT showed significant 28-days mortality benefit (61.5% vs. 15.4%).
The aim of this study is to investigate whether citrate post-dilution continuous venovenous hemofiltration (CVVH) using PMMA based hemofilter (PMMA-CVVH) in the treatment of patient with septic AKI provide better clinical outcome compared with CVVH using polysulfone based hemofilter (PS-CVVH)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32784 0
Dr Hoi-Ping SHUM
Address 32784 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Hong Kong SAR
Country 32784 0
Hong Kong
Phone 32784 0
+852-25956111
Fax 32784 0
Email 32784 0
[email protected]
Contact person for public queries
Name 16031 0
Dr Dr. Hoi-Ping Shum
Address 16031 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 16031 0
Hong Kong
Phone 16031 0
852-25956111
Fax 16031 0
Email 16031 0
[email protected]
Contact person for scientific queries
Name 6959 0
Dr Dr. Hoi-Ping Shum
Address 6959 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 6959 0
Hong Kong
Phone 6959 0
852-25956111
Fax 6959 0
Email 6959 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExtracorporeal blood purification for sepsis.2016https://dx.doi.org/10.12809/hkmj164876
N.B. These documents automatically identified may not have been verified by the study sponsor.