ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

From start to end of each session of CVVH that use citrate as regional anticoagulant

Secondary outcome [1]

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]

From start to end of each session of CVVH that use citrate as regional anticoagulant

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Individual

Name [1]

Dr Chan Choi Hung

Address [1]

B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong

Country [1]

Hong Kong

Secondary sponsor category [2]

Individual

Name [2]

Dr Shum Hoi Ping

Address [2]

B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong

Country [2]

Hong Kong

Secondary sponsor category [3]

Individual

Name [3]

Dr Chan King Chung

Address [3]

B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong

Country [3]

Hong Kong

Secondary sponsor category [4]

Individual

Name [4]

Dr Lai Kang Yiu

Address [4]

B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong

Country [4]

Hong Kong

Secondary sponsor category [5]

Individual

Name [5]

Dr Yan Wing Wa

Address [5]

B10 ICU
Pamela Youde Nethersole Eastern Hosptial
3 Lok Man Road,
Hong Kong

Country [5]

Hong Kong

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hospital Authority--Research Ethics Committee ( Kowloon Central/Kowloon East)

Ethics committee address [1]

Rm 712, Block S
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

27/11/2010

Approval date [1]

13/12/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Anne Leung

Address

B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong

Country

Hong Kong

Phone

852-2958-6363

Fax

852-2388-1231

leungkha@ha.org.hk

Contact person for scientific queries

Name

Dr Anne Leung

Address

B6 ICU
Queen Elizabeth Hospital
30 Gascoigne Road
Kowloon, Hong Kong

Country

Hong Kong

Phone

852-2958-6363

Fax

852-2388-1231

leungkha@ha.org.hk

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

Source	Title	Year of Publication	DOI
Dimensions AI	A Retrospective Review of the Use of Regional Citrate Anticoagulation in Continuous Venovenous Hemofiltration for Critically Ill Patients	2013	https://doi.org/10.1155/2013/349512

N.B. These documents automatically identified may not have been verified by the study sponsor.

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