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Trial registered on ANZCTR


Registration number
ACTRN12611000099921
Ethics application status
Approved
Date submitted
27/01/2011
Date registered
28/01/2011
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regional citrate anti-coagulation for continuous renal replacement therapy in patients with acute kidney injury
Scientific title
Regional Citrate Anti-Coagulation in Predilution Continuous Venovenous Haemofiltration Using citrate containing solution (Prismocitrate 10/2 solution)
Secondary ID [1] 253493 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 261042 0
Condition category
Condition code
Renal and Urogenital 259182 259182 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Prismaflex system (Gambro-Hospal) was used for predilution continuous venovenous hemofiltration (CVVH). Prismocitrate 10/2, running at 2500ml/h, was the main predilution replacement. 8.4% sodium bicarbonate solution was infused at 50ml/h in the first 2 hours, and then at 30ml/h, via the ‘Heparin port’ of the circuit (pre-filter). 10% calcium gluconate was infused via a separate central venous catheter to achieve an ionized calcium (iCa) level of 1-1.2mmol/L. The fluid withdrawal rate was adjusted to achieve the desired fluid balance. The circuit was run for 72-hours, unless there was filter clotting, requirement of transportation outside ICU for intervention/ imaging, or the patient did not require further CRRT
Intervention code [1] 257926 0
Treatment: Devices
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262034 0
Hemofilter life span
Timepoint [1] 262034 0
Circuit clotting criteria: visible extracorporeal circuit / filter clotting or transmembrane pressure >450mmHg
Starting and stopping time of continuous venovenous hemofiltration
Secondary outcome [1] 273004 0
Acid base changes
Timepoint [1] 273004 0
Check arterial blood gas at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [2] 273005 0
Sodium changes
Timepoint [2] 273005 0
Check serum sodim level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [3] 273006 0
Potassium changes
Timepoint [3] 273006 0
Check serum potassium level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [4] 273007 0
Total calcium changes
Timepoint [4] 273007 0
Check total serum calcium level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [5] 273008 0
ionized calcium changes
Timepoint [5] 273008 0
Check serum ionized calcium level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [6] 273009 0
Creatinine changes
Timepoint [6] 273009 0
Check serum creatinine level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr
Secondary outcome [7] 273010 0
Phosphate changes
Timepoint [7] 273010 0
Check serum phosphage level at starting of continuous venovenous hemofiltration (time 0hr), 1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr, 32hr, 40hr, 48hr, 56hr, 64hr and 72hr

Eligibility
Key inclusion criteria
All patients who received citrate containing solution (Prismocitrate 10/2) for predilution continuous venovenous hemofiltration during study period
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cases with insufficient data for analysis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3161 0
Hong Kong
State/province [1] 3161 0

Funding & Sponsors
Funding source category [1] 258398 0
Hospital
Name [1] 258398 0
Pamela Youde Nethersole Eastern Hospital
Address [1] 258398 0
3 Lok Man Road
Chai Wan
Country [1] 258398 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] 257541 0
None
Name [1] 257541 0
Address [1] 257541 0
Country [1] 257541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260371 0
Hong Kong East Cluster ethics committee
Ethics committee address [1] 260371 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Ethics committee country [1] 260371 0
Hong Kong
Date submitted for ethics approval [1] 260371 0
10/08/2010
Approval date [1] 260371 0
27/09/2010
Ethics approval number [1] 260371 0
HKEC-2010-065

Summary
Brief summary
Regional citrate anticoagulation (RCA) for continuous renal replacement therapy is associated with longer filter-life and less bleeding events. Complexity of the regimen is the major hurdle preventing its wide spread applications. Our intensive Care Unit has been using a concentrated citrate containing solution for continuous venovenous hemofiltration (CVVH) for more than ten years already. We have been using another proprietary product of diluted citrate solution (Prismocitrate 10/2, Gambro) for predilutional continuous veno-venous hemofiltration (CVVH) since 2009. This is a retrospective case review for patients received this diluted citrate solution (Prismocitrate 10/2, Gambro).
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32141 0
Dr Shum Hoi Ping
Address 32141 0
Department of Intensive Care, Pamela youde nethersole eastern hospital, Hong Kong
Country 32141 0
Hong Kong
Phone 32141 0
+852 25957128
Fax 32141 0
Email 32141 0
shumhp@ha.org.hk
Contact person for public queries
Name 15388 0
Dr Dr. Hoi-Ping Shum
Address 15388 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 15388 0
Hong Kong
Phone 15388 0
852-25956111
Fax 15388 0
Email 15388 0
shumhp@ha.org.hk
Contact person for scientific queries
Name 6316 0
Dr Dr. Hoi-Ping Shum
Address 6316 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 6316 0
Hong Kong
Phone 6316 0
852-25956111
Fax 6316 0
Email 6316 0
shumhp@ha.org.hk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary