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Trial registered on ANZCTR

Registration number

ACTRN12612000765820

Ethics application status

Approved

Date submitted

7/06/2012

Date registered

18/07/2012

Date last updated

18/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Filter Life In Renal Replacement Therapy

Scientific title

In critically ill patients with acute kidney injury does continuous renal replacement therapy (CRRT) using a machine controlled citrate protocol compared to a regional heparin protcocol improve safety and extend filter life.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1131-5352

Trial acronym

The FLIRRT Study

Linked study record

Health condition

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

Acute Kidney Injury

Renal Replacement Therapy

Condition category

Condition code

Renal and Urogenital

Kidney disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Gambro Prismaflex CRRT SW 6 supports control of citrate delivery in pre-blood-pump fluid and an algorithm to estimate calcium lost during citrate therapy and utilises this to control the rate of calcium replacement via a syringe driver. Our protocol determines the initial citrate and calicum replacement rates after which the performance of the system is monitored by regularly testing patient and circuit calicum levels with adjustments as required. The control arm is the standard regional heparin protocol (including criteria to escalate to protamine) that is in established use in the Alfred Intensive Care Unit.
CRRT will continue until the patient no longer requires it (recovery or move to permanent intermittent dialysis). This may result in periods off CRRT to assess adequacy of recovery. They will remain in the treatment arm unless a contra-indication develops or the treating physician withdraws.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Citrate based extracorporeal circuit anticoagulation vs the currently implemented Alfred ICU regional heparin (+/- protamine) circuit anticoagulation protocol.
Citrate is administered via pre-filtration fluid following a dosing protocol and implemented by software with monitoring of patient and circuit calcium. Heparin is given via a standard infusion pump at a protocol defined rate with APTT monitoring to avoid systemic anticoagulation.

Control group

Active

Outcomes

Primary outcome [1]

Circuit survival and filter life.

Timepoint [1]

Electronic logs from CRRT machines are downloaded throughout the study duration and incorporation of data with review of medical charts will be assessed at study completion.

Primary outcome [2]

Predefined safety end points:Severe metabolic acidosis / alkalosis, hypo/hypercalcemia (citrate only) severe citrate accumulation, Heparin Induced Thrombocytopenia (HIT), any other reaction to citrate, heparin or protamine. Any other adverse event deemed by the treating physician to be due to the treatment arm.

Timepoint [2]

During the time the patient is receiving CRRT or any event that precludes further treatment (eg bleeding or new liver failure) in the first 30 days when treatment is paused but be required again.

Primary outcome [3]

Treatment Efficacy: Control of uraemia: reduction of urea from baseline to level at Day 3. Time to urea < 25mmol/L. Acheivement and adherence to treatment arm protocol will be assessed by reviewing responses to calcium or APTT measurements that should have triggered alterations according to treatment protocol.

Timepoint [3]

During the time the patient is receiving CRRT

Secondary outcome [1]

Dialysis independence.

Timepoint [1]

At time of ICU and hospital discharge by review of ICU discharge record and phone follow up by research staff.

Secondary outcome [2]

Mortality

Timepoint [2]

90 days. Assessed by ICU computer database held for all Australian ICU patients and phone follow up by research staff

Eligibility

Key inclusion criteria

Greater than 18 years old
Diagnosis of acute renal failure with an indication for renal replacement therapy as assessed by one or more of the following criteria:Oliguria (urine output < 100ml in a 6hour period) unresponsive to fluid resuscitation;volume overload, not correctable by diuretics in spite of adequate blood pressure and creatinine > 100umol.L; increase of serum creatinine > 300 umol/L or BUN > 25mmol/L;increase of serum potassium > 6.5 mmol/L due to AKI

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patient weight < 30kg (determined by machine specification)

Inability to enter randomization due to a contraindication to one of the treatment arms:

Indication for systemic anticoagulation with heparin (therapeutic range APTT) or an equivalent therapeutic dose of low molecular weight heparin (note this does not include routine thromboprophylaxis with these agents)

Prior development of HIT

History of anaphylaxis to heparin, protamine or citrate.

Pregnancy, or lactation.

Patients on chronic renal replacement therapy prior to ICU presentation.

Indication for therapeutic hypothermia

Previous participation in the same study

Indication for a filter set other than the AN69 ST100 1m2 set or a specific dialysis prescription differing from the study protocol (as deemed by the treating physician)

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is concealed, randomisation is by a computer web based system.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Compter generated random number table

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Delayed Consent approved by ethics review committee.

Phase

Phase 3 / Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/03/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alfred Hospital

Address [1]

55 Commercial Rd
Prahran
VIC 3181

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Alfred Hospital Small Project Grant - $10,000

Address [2]

As Above

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr. Matthew Brain

Address

Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3141

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr. Owen Roodenburg

Address [1]

Dept Intensive Care Research
Alfred Hospital
55 Commercial Rd
Prahran
VIC 3141

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred HREC

Ethics committee address [1]

Alfred Hospital
55 Commercial Rd
Prahran
VIC 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

1/11/0396

Summary

Brief summary

Dialysis is the process of removing fluid and waste products from the blood of patients who have kidney failure. Most people may be familiar with conventional hemodialysis in specialized kidney wards, for patients who have kidney disease and are otherwise well. It is usually performed for around 4 hours, 3 days per week, however these short periods of high intensity dialysis are often not tolerated by the very sick who are better managed with less intense but continuous dialysis. 
This continuous type of dialysis is called Continuous Renal Replacement Therapy (CRRT) and it is continued in patients in ICU who have kidney failure, until the patient’s kidneys start to work again or they are well enough to move to intermittent dialysis in a kidney ward. 
During dialysis, blood from the patient is continuously circulated through a filter in the kidney machine, and waste products are removed. There is always the possibility that the blood may clot as it passes through the filter. Patient stability and carefully controlled fluid removal can be compromised if the kidney machine fails too frequently. The most common reason for failure is blood clotting inside the filter – the more this occurs, the less the patient actually receives treatment, and as each filter costs roughly $400 the treatment becomes increasingly expensive. If blood clotting is prevented inside the filter it can last longer - between 24 and 72 hours. Common methods to stop blood clotting (known as anti-coagulation) include adding heparin or citrate to the circuit in the dialysis machine.
The primary aim of this study is to compare the filter life using two methods of anticoagulation in CRRT in the Alfred Intensive Care Unit. 
The first method involves the use of a blood thinner called heparin. Sometimes when higher doses of heparin are required, another drug called protamine that reverses the blood thinning effect is added to the blood in kidney machine circuit. Adding heparin with or without protamine is the method that is currently most used at the Alfred for CRRT. 
The second method involves the use of citrate fluid in the kidney machine. The citrate binds with calcium and has an anticoagulant effect. Previously, this method proved more labor intensive for the nurses as additional pumps were needed. It tended to be used in special situations e.g. in patients who were allergic to heparin and/or could not receive blood thinners due to a high risk of bleeding. However, recent improvements in the technology of kidney machines have allowed this method to be used much more simply and efficiently. This study has been designed by our doctors at the Alfred Intensive Care Unit to find out if using citrate in the kidney machine is a better and safer way of using CRRT than using heparin in the kidney machine.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Shirley Vallance

Address

Dept ICU Research
55 Commercial Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 3 90768034

Fax

+61 3 907682343

s.vallance@alfred.org.au

Contact person for scientific queries

Name

Dr Mathew Brain

Address

Dept ICU Research
55 Commercial Rd
Prahran
VIC 3181

Country

Australia

Phone

+61 3 90763036

Fax

+61 3 90762343

mbrain@tassie.net.au

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	Randomised trial of software algorithm-driven regional citrate anticoagulation versus heparin in continuous renal replacement therapy: the Filter Life in Renal Replacement Therapy pilot trial	2014	https://doi.org/10.1016/s1441-2772(23)01454-0

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

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