Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000360910
Ethics application status
Approved
Date submitted
5/04/2011
Date registered
7/04/2011
Date last updated
7/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A retrospective review on the use of Regional citrate Anticoagulation (RCA) in Continuous Venovenous Hemofiltration (CVVH) for critically ill patients
Scientific title
In critically ill patients who required Continuous Venovenous Hemofiltration (CVVH), what is the effect of using Regional citrate anticoagulation (RCA) on circuit time, rate of correction of patient's metabolic acidosis and any untoward side effect?
Secondary ID [1] 259939 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients who required continuous venovenous hemofiltration 265552 0
Condition category
Condition code
Renal and Urogenital 265701 265701 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To observe the effect of using citrate as regional anticoagulation during CVVH during the period from 1st Jul to 31st Dec 2010

To observe the effect on circuit lifetime, the rate of correction of metabolic acidosis and any untoward side effect like accumulation of citrate, hypo or hypernatremia, hypo or hypercalcemia, metabolic acidosis or metabolic alkalosis
Intervention code [1] 264350 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266468 0
The lifttime of the CVVH circuit, ie how long did each session of CVVH last and for what reason that the dialysis was terminated, eg filter clot ect.
Timepoint [1] 266468 0
From start to end of each session of CVVH that use citrate as regional anticoagulant
Secondary outcome [1] 273833 0
Rate of correction of patient's metabolic acidosis. We would like to investigate how fast the underlying metabolic acidosis ( using base deficit as the surrogate) was corrected over time by taking blood every 4 hourly.
Timepoint [1] 273833 0
From start to end of each session of CVVH that use citrate as regional anticoagulant
Secondary outcome [2] 273834 0
Side effect of using citrate eg
1. accumulation of citrate
2. Hypo or hyper natremia
3. Hypo or hyper calcemia
4. Metabolic acidosis or metabolic alkalosis

by meauring the renal function, arterial blood gas and ionized calcium every 4 hourly. If suspcious of accumulation of citrate, additional blood for anion gap, Chloride and total calcium/ionized calcium ratio will be measured.
Timepoint [2] 273834 0
From start to end of each session of CVVH that use citrate as regional anticoagulant

Eligibility
Key inclusion criteria
CVVH with regional citrate anticoagulant that last for more than 4 hours
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
CVVH not using regional citrate as anticoagulant
session of CVVH last less than 4 hours

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3341 0
Hong Kong
State/province [1] 3341 0

Funding & Sponsors
Funding source category [1] 264816 0
Self funded/Unfunded
Name [1] 264816 0
Country [1] 264816 0
Primary sponsor type
Individual
Name
Dr Anne Leung
Address
B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 263922 0
Individual
Name [1] 263922 0
Dr Chan Choi Hung
Address [1] 263922 0
B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Country [1] 263922 0
Hong Kong
Secondary sponsor category [2] 263923 0
Individual
Name [2] 263923 0
Dr Shum Hoi Ping
Address [2] 263923 0
B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong
Country [2] 263923 0
Hong Kong
Secondary sponsor category [3] 263924 0
Individual
Name [3] 263924 0
Dr Chan King Chung
Address [3] 263924 0
B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong
Country [3] 263924 0
Hong Kong
Secondary sponsor category [4] 263925 0
Individual
Name [4] 263925 0
Dr Lai Kang Yiu
Address [4] 263925 0
B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Country [4] 263925 0
Hong Kong
Secondary sponsor category [5] 263926 0
Individual
Name [5] 263926 0
Dr Yan Wing Wa
Address [5] 263926 0
B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong
Country [5] 263926 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266786 0
Hospital Authority--Research Ethics Committee ( Kowloon Central/Kowloon East)
Ethics committee address [1] 266786 0
Rm 712, Block S
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Ethics committee country [1] 266786 0
Hong Kong
Date submitted for ethics approval [1] 266786 0
27/11/2010
Approval date [1] 266786 0
13/12/2010
Ethics approval number [1] 266786 0
KC/KE-10-0214/ER-3

Summary
Brief summary
Use of citrate as regional anticoagulant had been demonstrated to associate with longer filter-life, less bleeding events and improved mortality. It is superior to unfractionated heparin in prolonging filter lifetime and the anticoagulant effect is limited within the circuit without systemic disturbances. However, the complex set up and training required had limited the widespread use of citrate. In recent years, the availability of this commercial prepared pre-mixed citrate solution had greatly simplified its use and had been published in various studies as well as a local case series. The proprietary diluted citrate solution available in Hong Kong is the Prismocitrate 10/2, Gambro, which contains 10 mmol/L of trisodium citrate and 2mmol/L of citric acid. Based on these clinical studies, our unit had modified our regional citrate CVVH regime since July 2010 and demonstrated satisfactory result. We would like to conduct a retrospective study to evaluate its effect on circuit patency, rate of correction of the patient’s metabolic disorder and any untoward electrolyte imbalance after applying this regime in a heterogeneous group of critically ill patients
Trial website
Trial related presentations / publications
1.Uchino S. The epidemiology of acute renal failure in the world. Curr Opin Crit Care 2006;12:538-43.
2.Uchino S, Bellomo R, Kellum JA, et al. Patient and kidney survival by dialysis modality in critically ill patients with acute kidney injury. Int J Artif Organs 2007;30:281-92.
3.Monti G, Herrera M, Kindgen-Milles D, et al. The DOse REsponse Multicentre International Collaborative Initiative (DO-RE-MI). Contrib Nephrol 2007;156:434-43.
4.Oudemans-van Straaten HM, Bosman RJ, Koopmans M, van der Voort PH, Wester JP, van der Spoel JI, Dijksman LM, Zandstra DF. Citrate anticoagulation for continuous venovenous hemofiltration. Crit Care Med. 2009 Feb;37(2):545-52
5.Bihorac A, Ross EA. Continuous venovenous hemofiltration with citrate-based replacement fluid: efficacy, safety, and impact on nutrition. Am J Kidney Dis. 2005 Nov;46(5):908-18.
6.A comparison of two citrate anticoagulation regimens for continuous veno-venous hemofiltration. Egi M, Naka T, Bellomo R, et al. Int J Artif Organs 2005 Dec; 28(12):1211-8
7.Comparison of the efficacy and safety of two regional citrate anticoagulation protocols using acid citrate dextrose A or Prismocitrate 10/2, in patients with acute renal failure udergoing continuous venovenous hemodiafiltration. EL Ooi, TW Lim and N Lim. Critical Care 2010,14 (Suppl 1): P515
Public notes

Contacts
Principal investigator
Name 32444 0
Address 32444 0
Country 32444 0
Phone 32444 0
Fax 32444 0
Email 32444 0
Contact person for public queries
Name 15691 0
Dr Anne Leung
Address 15691 0
B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Country 15691 0
Hong Kong
Phone 15691 0
852-2958-6363
Fax 15691 0
852-2388-1231
Email 15691 0
[email protected]
Contact person for scientific queries
Name 6619 0
Dr Anne Leung
Address 6619 0
B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong
Country 6619 0
Hong Kong
Phone 6619 0
852-2958-6363
Fax 6619 0
852-2388-1231
Email 6619 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
Dimensions AIA Retrospective Review of the Use of Regional Citrate Anticoagulation in Continuous Venovenous Hemofiltration for Critically Ill Patients2013https://doi.org/10.1155/2013/349512
N.B. These documents automatically identified may not have been verified by the study sponsor.