ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000297820

Ethics application status

Approved

Date submitted

13/03/2012

Date registered

15/03/2012

Date last updated

12/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Early vs. late initiation of continuous renal replacement therapy in patient suffering from septic shock and acute renal failure

Scientific title

Timing for initiation of continuous renal replacement therapy in patients with septic shock and acute kidney injury

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Septic shock

Acute kidney injury

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

The aim of this study is to investigate the impact of early versus late initiation of continuous renal replacement therapy (CRRT) as defined by using the simplified RIFLE classification, on organ dysfunction among patients with septic shock and acute kidney injury. Medical records of those patients who were admitted into our intensive care unit from 2008 to 2011 and required CRRT were reviewed. Those fulfilled the inclusion criteria and without exclusion criteria are recruited for further data analysis. The observation period started at the time of CRRT initiation (time zero) to 6 months after started CRRT.

Intervention code [1]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Sequential Organ Failure Assessment (SOFA) score

Timepoint [1]

Time 0, 24 and 48 hours after initiation of CRRT

Secondary outcome [1]

Vasopressor dosage (based on medical records charted vasopressor dosage)

Timepoint [1]

Time 0, 24 and 48 hours after initiation of CRRT

Secondary outcome [2]

ICU mortality (based on medical records upon ICU discharge)

Timepoint [2]

Upon ICU discharge

Secondary outcome [3]

Hospital mortality (based on medical records upon hospital discharge)

Timepoint [3]

Upon hospital discharge

Secondary outcome [4]

ICU length of stay (based on medical records upon ICU discharge)

Timepoint [4]

Upon ICU discharge

Secondary outcome [5]

Hospital length of stay (based on medical records upon hospital discharge)

Timepoint [5]

Upon hospital discharge

Secondary outcome [6]

Mortality (based on medical records, cross cluster electronic patient records or direct telephone contact)

Timepoint [6]

28 days, 3 months and 6 months

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 CRRT), and
3. Presence of shock (defined as mean arterial pressure <=65mmHg and required vasopressor support), either at the start or during CRRT

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Presence of Chronic kidney disease stage 5 or on regular dialysis support, or
2. Pregnancy

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

20/03/2012

Actual

20/03/2012

Date of last participant enrolment

Anticipated

Actual

30/04/2012

Date of last data collection

Anticipated

Actual

30/04/2012

Sample size

Target

150

Accrual to date

Final

120

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

Shum Hoi Ping

Address

Department of intensive care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan

Country

Hong Kong

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hong Kong East Cluster Ethics Committee

Ethics committee address [1]

Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

18/12/2011

Approval date [1]

06/03/2012

Ethics approval number [1]

HKEC-2011-92

Summary

Brief summary

Acute kidney injury (AKI) affects 5% to 7% of all hospitalized patients (1-2). 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 (3). The optimal timing for initiation of renal replacement therapy (RRT) in septic AKI remains controversial. The main reason is the absence of a clear and consensual definition of AKI to stratify patients according to the degree of renal impairment. The development of new system, like Risk, Injury, Failure , Loss of kidney function, and End -stage renal failure (RIFLE) classification represent a major step forward (4).  Recent meta-analysis showed that earlier initiation of RRT in AKI may have a beneficial impact on survival (5).  However, the conclusion is based on heterogeneous studies of variable quality.  Moreover, the causes of AKI differ between studies, with less than half of the included cases were due to sepsis. In fact, the author concluded that a definitive treatment recommendation on timing of RRT in AKI cannot be made.  The aim of this study is to investigate the impact of early versus late initiation of continuous renal replacement therapy (CRRT) as defined by using the simplified RIFLE classification, on organ dysfunction among patients with septic shock and AKI. We hypotheized that early CRRT in septic shock can decrease organ dysfunction.  Medical records of those patient who were admited into our intensive care unit from 2008 to 2011 and required CRRT support are reviewed.  Those fulfiled the inclusion criteria and without exclusion criteria are recruited for further data analyisis.  

1.	Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8.
2.	Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6.
3.	Silvester W, Bellomo R, Cole L. Epidemiology, management, and outcome of severe acute renal failure of critical illness in Australia. Crit Care Med. 2001 Oct;29(10):1910-5.
4.	Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12.
5.	Karvellas CJ, Farhat MR, Sajjad I, Mogensen SS, Leung AA, Wald R, et al. A comparison of early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury: a systematic review and meta-analysis. Crit Care. 2011;15(1):R72.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong SAR

Country

Hong Kong

Phone

+852-25956111

Fax

shumhp@ha.org.hk

Contact person for public queries

Name

Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan

Country

Hong Kong

Phone

852-25956111

Fax

shumhp@ha.org.hk

Contact person for scientific queries

Name

Dr Shum Hoi Ping

Address

Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan

Country

Hong Kong

Phone

852-25956111

Fax

shumhp@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

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No additional documents have been identified.

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