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Trial registered on ANZCTR


Registration number
ACTRN12614001000695
Ethics application status
Approved
Date submitted
5/09/2014
Date registered
16/09/2014
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Experiences with a new regional citrate anticoagulation protocol for continuous venovenous hemofiltration using a phosphate containing replacement solution in critically ill patients
Scientific title
Regional citrate anticoagulation for continuous venovenous hemofiltration using Prismocitrate 18/0 and a phosphate containing replacement solution (Phoxilium) for critically ill patients: Effect on filter life and acid-base changes
Secondary ID [1] 285294 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 292962 0
Critical illness 293041 0
Condition category
Condition code
Renal and Urogenital 293256 293256 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Citrate CVVH was performed using either of the following 2 machines: Prismaflex machine (Gambro-Hospal) with a high-flux hemofilter (HF 1400/ ST 100) or MultiFiltrate (Fresenius Medical Care) with the Ultraflux AV 600S hemofilter. The blood flow rate was maintained at 110ml/min, Prismocitrate 18/0 solution running at a fixed rate of 1250 ml/h as predilution replacement fluid, Phoxilium solution at 1250ml/h as post-dilution replacement fluid. Blood samples for urea/ creatinine/ acid-base/ total calcium/ ionized calcium/ pre-filter ionzied calcium/ post-filter ionized calcium were taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs for monitoring purpose. Additional blood tests were performed as indicated based on clinical indications. Concentrated calcium infusion (10% Calcium chloride) was infused via a separate central line and was titrated to achieve a systemic iCa level of 1–1.2 mmol/L. The fluid withdrawal rate was adjusted to achieve the desired fluid balance. The circuit was run for 72 h unless there was filter clotting, transportation outside ICU, or the patient did not require additional CRRT.
Intervention code [1] 290195 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293108 0
Hemofilter life span as determined by time to circuit clotting criteria reached and no more than 72 hours
Timepoint [1] 293108 0
Circuit clotting criteria: hourly inspections for visible extracorporeal circuit / filter clotting, or transmembrane pressure >450mmHg, up to a maximum of 72 hours
Secondary outcome [1] 310351 0
Serum urea changes
Timepoint [1] 310351 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [2] 310443 0
Serum creatinine changes
Timepoint [2] 310443 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [3] 310444 0
Serum acid-base changes
Timepoint [3] 310444 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [4] 310445 0
Serum sodium changes
Timepoint [4] 310445 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [5] 310446 0
Serum potassium changes
Timepoint [5] 310446 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [6] 310447 0
Serum magnesium changes
Timepoint [6] 310447 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [7] 310448 0
Serum total calcium changes
Timepoint [7] 310448 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [8] 310449 0
Serum ionized calcium changes
Timepoint [8] 310449 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [9] 310450 0
Serum pre-filter ionized calcium changes
Timepoint [9] 310450 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs
Secondary outcome [10] 310451 0
Serum post-filter ionized calcium changes
Timepoint [10] 310451 0
Blood samples taken at time 0, 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72hrs

Eligibility
Key inclusion criteria
All patients who underwent CVVH using Prismocitrate 18/0 and Phoxilium during the study period
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
1/11/2014
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
1/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 6339 0
Hong Kong
State/province [1] 6339 0
Hong Kong

Funding & Sponsors
Funding source category [1] 289914 0
Hospital
Name [1] 289914 0
Queen Elizabeth Hospital
Country [1] 289914 0
Hong Kong
Primary sponsor type
Hospital
Name
Intensive Care Unit, Queen Elizabeth Hospital
Address
30 Gascoigne Road
Kowloon
Country
Hong Kong
Secondary sponsor category [1] 288605 0
None
Name [1] 288605 0
Address [1] 288605 0
Country [1] 288605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291633 0
Kowloon Central / Kowloon East Cluster Research Ethics Committee
Ethics committee address [1] 291633 0
Room 808, Block S, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
Ethics committee country [1] 291633 0
Hong Kong
Date submitted for ethics approval [1] 291633 0
10/09/2014
Approval date [1] 291633 0
01/10/2014
Ethics approval number [1] 291633 0

Summary
Brief summary
Acute kidney injury is common in critically ill patients and hence continuous renal replacement therapy (CRRT) is an important treatment modality in intensive care. Clotting of the circuit is a major factor contributed to treatment interruption. Regional citrate anticoagulation (RCA) for CRRT is associated with longer filter-life, less bleeding events and improved mortality. We previously reported the use of the Prismocitate 10/2 with good metabolic control and median circuit filter life range from 50 to 26 hrs. Yet, hypomagnesaemia (41.6%) and hypophosphatemia (17.6%) were two commonly encountered electrolyte anomalies during citrate CRRT. Besides, additional sodium bicarbonate infusion was used in all the patients to provide adequate buffer balance. To circumvent all these problems, another proprietary citrate containing solution (Prismocitrate 18/0, Gambro) and phosphate containing hemofiltration solution (Phoxilim) had been used in combination with success in a number of studies. We would like to assess whether or not the combined used of these solutions can provide a safe and effective alternative for critically ill patients who required CRRT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51250 0
Dr Henry Jeffrey Yuen
Address 51250 0
Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
Country 51250 0
Hong Kong
Phone 51250 0
+85229586363
Fax 51250 0
Email 51250 0
[email protected]
Contact person for public queries
Name 51251 0
Henry Jeffrey Yuen
Address 51251 0
Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
Country 51251 0
Hong Kong
Phone 51251 0
+85229586363
Fax 51251 0
Email 51251 0
[email protected]
Contact person for scientific queries
Name 51252 0
Henry Jeffrey Yuen
Address 51252 0
Intensive Care Unit, Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon
Country 51252 0
Hong Kong
Phone 51252 0
+85229586363
Fax 51252 0
Email 51252 0
[email protected]

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Results publications and other study-related documents

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