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Trial registered on ANZCTR


Registration number
ACTRN12617001461381
Ethics application status
Approved
Date submitted
17/09/2017
Date registered
16/10/2017
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
GELATIne fluid and acute kidney injury in critical illness: the GELATI trial
Scientific title
The effect of 4% succinylated gelatine fluid on acute kidney injury in critically ill patients
Secondary ID [1] 292841 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GELATI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 304684 0
Circulatory failure
304754 0
Acute kidney injury 304934 0
Condition category
Condition code
Cardiovascular 303996 303996 0 0
Other cardiovascular diseases
Renal and Urogenital 304264 304264 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous 4% succinylated gelatine fluid at a dose of at least 500mL, to be delivered over less than 60 minutes, Exact dose will be determined by treating physician. The study fluid will also be used for any further fluid boluses required within the next 24-hour period, up to a maximum of 50mL/kg or 3000mL. Any fluid required for blood volume expansion beyond 24 hours is open-label; however, the use of gelatine will be not allowed for 7 days post-enrolment. Other crystalloid fluids or blood products may be used for purposes other than blood volume expansion, such as maintenance requirements or transfusion. Use of albumin solution is also permitted, if specifically indicated. Volume and type of all fluids delivered with 7 days of enrolment, or until ICU discharge, will be recorded.
Intervention code [1] 299088 0
Treatment: Drugs
Comparator / control treatment
Intravenous compound sodium lactate at a dose of at least 500mL, to be delivered over less than 60 minutes, Exact dose will be determined by treating physician. The study fluid will also be used for any further fluid boluses required within the next 24-hour period, up to a maximum of 50mL/kg or 3000mL.
Control group
Active

Outcomes
Primary outcome [1] 303328 0
A difference in the change in urine NGAL concentrations over time after first dose of study fluid
Timepoint [1] 303328 0
0, 1, 5 and 24 hours
Primary outcome [2] 303544 0
A difference in the change in urine cystatin C concentrations over time after first dose of study fluid
Timepoint [2] 303544 0
0, 1, 5 and 24 hours
Secondary outcome [1] 338654 0
Urinary F2-isoprostanes concentration
Timepoint [1] 338654 0
0, 1, 5 and 24 hours
Secondary outcome [2] 338655 0
Maximum KDIGO AKI stage within 7 days after randomisation
Timepoint [2] 338655 0
7 days
Secondary outcome [3] 338656 0
RRT-free days within 28 days after randomisation
Timepoint [3] 338656 0
28 days
Secondary outcome [4] 338657 0
60-day all-cause mortality
Timepoint [4] 338657 0
60 days
Secondary outcome [5] 339287 0
Urinary a1-microglobulin concentration
Timepoint [5] 339287 0
0, 1, 5, and 24 hours
Secondary outcome [6] 339288 0
ICU-free days within 28 days after randomisation
Timepoint [6] 339288 0
28 days

Eligibility
Key inclusion criteria
1. Patient within 96 hours of ICU admission
2. Treating physician has made a clinical decision to administer a fluid bolus at a dose of at least 500mL delivered over <60 minutes
3. Presence of a urinary collection system
4. Treating physician believes there is an equipoise in using either GELO or CSL for intravascular volume expansion.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. When an intravenous fluid bolus is not intended or planned on a clinical ground
2. Age <18 years old
3. Imminent death and/or limitation of care order
4. Severe chronic renal failure (creatinine >265µmol/L prior to acute illness, or end-stage renal failure receiving chronic dialysis)
5. Urine output <10mL/hr over the previous 4 hours
6. Currently receiving RRT, or planned RRT within the next 24 hours
7. Known allergy to GELO
8. Has received GELO in the previous 48 hours
9. Patient has been admitted to ICU for longer than 96 hours
10. Previous enrolment in the study
11. Treating clinician perceives that participation in the study is not in the patient’s best interests

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)
Numbered sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised block design of 4 blocks per treatment arm (2x4, 2x6) generated by statistical package software (Stata, College Station, TX, USA).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
Change in biomarker concentration over time will be compared between the placebo and GELO groups using a linear treatment effects model with propensity scoring adjustment for APACHE II score and admission diagnosis group. For biomarkers with skewed distributions that are resistant to successful transformation, quantile regression will be employed to compare differences over time. Ordinal logistic regression methods will be used for testing differences in maximum AKI stage, and logistic regression for differences in binary clinical outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8967 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 8968 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 17463 0
6150 - Murdoch
Recruitment postcode(s) [2] 17464 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 297474 0
Charities/Societies/Foundations
Name [1] 297474 0
Royal Perth Hospital Medical Research Foundation
Address [1] 297474 0
76 Murray St Perth, WA 6000
Country [1] 297474 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Royal Perth Hospital Medical Research Foundation
Address
76 Murray St Perth, WA 6000
Country
Australia
Secondary sponsor category [1] 296470 0
None
Name [1] 296470 0
Address [1] 296470 0
Country [1] 296470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298577 0
South Metropolitan Health Service Ethics Committee
Ethics committee address [1] 298577 0
Level 3, Harry Perkins Institute of Medical Research, Fiona Stanley Hospital
11 Robin Warren Drive, MURDOCH WA 6150
Ethics committee country [1] 298577 0
Australia
Date submitted for ethics approval [1] 298577 0
01/04/2017
Approval date [1] 298577 0
31/08/2017
Ethics approval number [1] 298577 0
RGS0000000105

Summary
Brief summary
Synthetic colloid fluids are frequently used for blood volume expansion in critically ill patients. Starch-based synthetic colloid fluids have been associated with increased risk of acute kidney injury. There is some evidence that gelatine-based colloid fluids may also pose a similar risk. This randomised open-label controlled pilot trial will assess the effects of 4% succinylated gelatine fluid on urinary biomarkers of acute kidney injury in Intensive Care Unit (ICU) patients. This study will also assess clinical outcomes, as secondary endpoints, including change in AKI stage, need for renal replacement therapy (RRT), ICU length of stay and mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77534 0
A/Prof Kwok Ming Ho
Address 77534 0
Intensive Care Unit, Royal Perth Hospital
Wellington St
Perth, WA, 6001
Country 77534 0
Australia
Phone 77534 0
+618 92241056
Fax 77534 0
Email 77534 0
kwok.ho@health.wa.gov.au
Contact person for public queries
Name 77535 0
Dr Lisa Smart
Address 77535 0
Murdoch University
90 South St
Murdoch, WA 6150
Country 77535 0
Australia
Phone 77535 0
+618 9360 6692
Fax 77535 0
Email 77535 0
l.smart@murdoch.edu.au
Contact person for scientific queries
Name 77536 0
Dr Lisa Smart
Address 77536 0
Murdoch University
90 South St
Murdoch, WA 6150
Country 77536 0
Australia
Phone 77536 0
+618 9360 6692
Fax 77536 0
Email 77536 0
l.smart@murdoch.edu.au

No data has been provided for results reporting
Summary results
Not applicable