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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] 280112 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic shock 286029 0
Acute kidney injury 286030 0
Condition category
Condition code
Renal and Urogenital 286219 286219 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 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] 284443 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286694 0
Sequential Organ Failure Assessment (SOFA) score
Timepoint [1] 286694 0
Time 0, 24 and 48 hours after initiation of CRRT
Secondary outcome [1] 296473 0
Vasopressor dosage (based on medical records charted vasopressor dosage)
Timepoint [1] 296473 0
Time 0, 24 and 48 hours after initiation of CRRT
Secondary outcome [2] 296474 0
ICU mortality (based on medical records upon ICU discharge)
Timepoint [2] 296474 0
Upon ICU discharge
Secondary outcome [3] 296475 0
Hospital mortality (based on medical records upon hospital discharge)
Timepoint [3] 296475 0
Upon hospital discharge
Secondary outcome [4] 296476 0
ICU length of stay (based on medical records upon ICU discharge)
Timepoint [4] 296476 0
Upon ICU discharge
Secondary outcome [5] 296477 0
Hospital length of stay (based on medical records upon hospital discharge)
Timepoint [5] 296477 0
Upon hospital discharge
Secondary outcome [6] 296478 0
Mortality (based on medical records, cross cluster electronic patient records or direct telephone contact)
Timepoint [6] 296478 0
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?
No
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] 4198 0
Hong Kong
State/province [1] 4198 0

Funding & Sponsors
Funding source category [1] 284875 0
Self funded/Unfunded
Name [1] 284875 0
Country [1] 284875 0
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] 283754 0
None
Name [1] 283754 0
Address [1] 283754 0
Country [1] 283754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286862 0
Hong Kong East Cluster Ethics Committee
Ethics committee address [1] 286862 0
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Ethics committee country [1] 286862 0
Hong Kong
Date submitted for ethics approval [1] 286862 0
18/12/2011
Approval date [1] 286862 0
06/03/2012
Ethics approval number [1] 286862 0
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 33897 0
Dr Dr Shum Hoi Ping
Address 33897 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong SAR
Country 33897 0
Hong Kong
Phone 33897 0
+852-25956111
Fax 33897 0
Email 33897 0
shumhp@ha.org.hk
Contact person for public queries
Name 17144 0
Dr Dr Shum Hoi Ping
Address 17144 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 17144 0
Hong Kong
Phone 17144 0
852-25956111
Fax 17144 0
Email 17144 0
shumhp@ha.org.hk
Contact person for scientific queries
Name 8072 0
Dr Dr Shum Hoi Ping
Address 8072 0
Department of Intensive Care
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road
Chai Wan
Country 8072 0
Hong Kong
Phone 8072 0
852-25956111
Fax 8072 0
Email 8072 0
shumhp@ha.org.hk

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