Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000030774p
Ethics application status
Submitted, not yet approved
Date submitted
16/11/2021
Date registered
14/01/2022
Date last updated
14/01/2022
Date data sharing statement initially provided
14/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does conservative fluid therapy compared to usual care change the outcomes in critically ill patients with acute kidney injury.
Scientific title
Renal Enhanced Support by Preventing Excessive fluid with Conservative fluid Therapy in acute kidney injury
Secondary ID [1] 305807 0
nil known
Universal Trial Number (UTN)
U1111-1271-6538
Trial acronym
RESPECT trial
Linked study record
n.a

Health condition
Health condition(s) or problem(s) studied:
acute kidney injury 324323 0
critical illness 324324 0
Condition category
Condition code
Renal and Urogenital 321816 321816 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial intervention will be a conservative fluid protocol (CFP), which will empower treating clinician to achieve daily negative fluid balances after randomisation. The CFP will consist of bundle of therapies targeting fluid input and fluid output to guide the treating team to achieve targets.

The trial intervention will be applied for seven days, or until discharge from the ICU. The intervention will only be applied when the patient is admitted to the ICU, it will not be applied in a ward based setting.

Aim
• Achieve a daily negative daily fluid balance (FB)
Methods
• Implementation of conservative fluid protocol interventions
• Recommend formal twice-daily assessment of fluid balance
- All required interventions listed below will be used to achieve target FB
Interventions
1. No maintenance intravenous (IV) fluids
a. IV fluids no greater than 10ml/hr
b. IV fluids for medications permitted
c. Exception when unable to provide fluid via enteral or parenteral nutrition
2. Early commencement of diuretic therapy if unable to achieve negative fluid balance
a. Commence when fluid balance goals not met
b. Choice of drug as per treating clinician
c. Dose escalation if not meeting FB goals
3. Concentrated enteral nutrition when feasible
a. Parenteral nutrition allowed, as per treating clinician
4. Concentrated antibiotics and medications when feasible

Adherence will be monitored by local research staff who will monitor the fluid balance of patients randomised to RFP. If the targets are not being met they will discuss with the clinical staff.
Intervention code [1] 322205 0
Treatment: Other
Comparator / control treatment
Usual care will be provided to the control group as per unit policies and guidelines. The treating clinician will be responsible for all decisions regarding intravenous fluid, diuretics, nutrition and fluid balance management. There will be no fluid balance target provided to control group.
Control group
Active

Outcomes
Primary outcome [1] 329572 0
Fluid balance from randomisation
Assessed using data-linkage to electronic medical records
Timepoint [1] 329572 0
From randomisation to 72 hours
Primary outcome [2] 329573 0
Peak serum creatinine from randomisation
Timepoint [2] 329573 0
From randomisation to day seven, or discharge from ICU
Assessed using data-linkage to electronic medical records
Assessed daily
Secondary outcome [1] 403061 0
Delta serum creatinine, difference between randomisation creatinine
Timepoint [1] 403061 0
From randomisation to Day 7 or ICU discharge
Using daily max creatinine every day to day 7 or ICU discharge
Secondary outcome [2] 403062 0
Duration acute kidney injury
Assessed using data-linkage to electronic medical records
Timepoint [2] 403062 0
From randomisation to Day 7 or ICU discharge
Secondary outcome [3] 403063 0
Severity of acute kidney injury
Assessed using data-linkage to electronic medical records
Timepoint [3] 403063 0
From randomisation to Day 7 or ICU discharge
Secondary outcome [4] 403064 0
Fluid balance
Assessed using data-linkage to electronic medical records
Timepoint [4] 403064 0
From randomisation to day 7 or ICU discharge
Secondary outcome [5] 403065 0
compliance with conservative fluid protocol
Assessed using data-linkage to electronic medical records
Timepoint [5] 403065 0
from randomisation to day 7 or ICU discharge
Secondary outcome [6] 403067 0
Time-weighted serum creatinine from randomisation
Assessed using data-linkage to electronic medical records
Timepoint [6] 403067 0
from randomisation to day 7, or ICU discharge
Secondary outcome [7] 403068 0
duration of mechanical ventilation
Assessed using data-linkage to electronic medical records
Timepoint [7] 403068 0
from randomisation to day 90
Secondary outcome [8] 403069 0
need for renal replacement therapy
Assessed using data-linkage to electronic medical records
Timepoint [8] 403069 0
from randomisation to day 90
Secondary outcome [9] 403074 0
duration of renal replacement therapy
Assessed using data-linkage to electronic medical records
Timepoint [9] 403074 0
from randomisation to day 90
Secondary outcome [10] 403075 0
renal replacement therapy dependence
Assessed using data-linkage to electronic medical records
Timepoint [10] 403075 0
from randomisation to day 90
Secondary outcome [11] 403076 0
ICU length of stay
Assessed using data-linkage to electronic medical records
Timepoint [11] 403076 0
from randomisation to day 90
Secondary outcome [12] 403077 0
hospital length of stay
Assessed using data-linkage to electronic medical records
Timepoint [12] 403077 0
from randomisation to day 90
Secondary outcome [13] 403078 0
ICU mortality
Assessed using data-linkage to electronic medical records
Timepoint [13] 403078 0
from randomisation to day 90
Secondary outcome [14] 403079 0
hospital mortality
Assessed using data-linkage to electronic medical records
Timepoint [14] 403079 0
from randomisation to day 90
Secondary outcome [15] 403080 0
mortality
Assessed using data-linkage to electronic medical records
Timepoint [15] 403080 0
from randomisation to day 90
Secondary outcome [16] 404401 0
Hyponatraemia
Assessed using data-linkage to electronic medical records
Timepoint [16] 404401 0
From randomisation to Day 7
Secondary outcome [17] 404402 0
Hypernatraemia
Assessed using data-linkage to electronic medical records
Timepoint [17] 404402 0
From randomisation to Day 7
Secondary outcome [18] 404403 0
Hypokalaemia
Assessed using data-linkage to electronic medical records
Timepoint [18] 404403 0
From randomisation to Day 7
Assessed using data-linkage to electronic medical records
Secondary outcome [19] 404404 0
Hyperkalaemia
Assessed using data-linkage to electronic medical records
Timepoint [19] 404404 0
From randomisation to Day 7
Secondary outcome [20] 404405 0
Cardiac arrhythmias
Assessed using data-linkage to electronic medical records
Presence of cardiac arrhythmias is record in the electronic medical record
Timepoint [20] 404405 0
From randomisation to Day 7

Eligibility
Key inclusion criteria
• Adult patient, age >=18
• Admitted to the intensive care unit for less than 72 hours
• Acute kidney injury defined by any of the following:
o >= 1.5 times baseline creatinine (assume normal if baseline unknown)
OR
o >= 27 umol/L (0.3mg/dL) absolute increase in creatinine
OR
o < 0.5ml/kg/hr urine output for at least 6 hours
• Deemed to be adequately fluid resuscitated as per treating clinician’s assessment
• Patient to remain in ICU until the day after tomorrow
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Maintenance fluid deemed necessary (e.g. for diabetic ketoacidosis or severe burns)
• Requirement for RRT, such as dialysable toxin
• Commencement of RRT for AKI is likely in the next 6 hours
• Chronic haemodialysis or peritoneal dialysis
• Acute renal transplant
• Presence or strong suspicion of post-renal obstruction
• Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L)
• Need for extracorporeal membrane oxygenation
• Previous enrolment in this study
• Pregnant or lactating
• Patients who are not to receive full active treatment

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with stratification by study site
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis will be performed on an intention-to-treat basis. Summary statistics will be used to describe the clinical data and presented as mean ± SD, median with interquartile range (IQR) or percentages as appropriate. Chi-squared analysis with Fisher’s exact test (when appropriate), and Student’s t-test (Mann Whitney U test for non-normal distributions) will be used to compare data between the active treatment group and the control group with statistical significance declared for probability values of 0.05 or less. Analysis of the outcome of excluded patients (e.g. due to other trials) will be performed in accordance with the CONSORT guidelines. A complete and finalised statistical analysis plan will be prepared and made available before the recruitment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
293
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 21103 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 21104 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 21105 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 21106 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 21107 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [6] 21108 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 21109 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 35961 0
3084 - Heidelberg
Recruitment postcode(s) [2] 35963 0
4029 - Herston
Recruitment postcode(s) [3] 35962 0
4032 - Chermside
Recruitment postcode(s) [4] 35959 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 35960 0
4215 - Southport
Recruitment postcode(s) [6] 35964 0
4575 - Birtinya
Recruitment postcode(s) [7] 35965 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 310158 0
Government body
Name [1] 310158 0
Metro South Hospital and Health Service
Country [1] 310158 0
Australia
Primary sponsor type
Government body
Name
Metro South Hospital and Health Service
Address
Metro South Health Office
Building 5, Garden City Office Park
2404 Logan Road
Eight Mile Plains Qld 4113
Country
Australia
Secondary sponsor category [1] 311244 0
None
Name [1] 311244 0
Address [1] 311244 0
Country [1] 311244 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309847 0
Metro South HREC
Ethics committee address [1] 309847 0
Metro South HREC
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 309847 0
Australia
Date submitted for ethics approval [1] 309847 0
16/11/2021
Approval date [1] 309847 0
Ethics approval number [1] 309847 0

Summary
Brief summary
The RESPECT trial aims to determine the clinical impact of a conservative fluid protocol (CFP), that is minimizing fluid administered and maximizing urine
produced, compared to usual care in patients admitted to the intensive care unit and have an acute impairment in their kidney function. The hypothesis is
that a CFP will result is less severe derangement in kidney function and will result in better patient outcomes, such as less need for dialysis. This will be
done by randomizing patients to one of the two groups: CFP and usual care. The expected outcomes are divided into feasibility and clinical outcomes. The
main feasibility outcome will be a difference in fluid administered after three days between the two groups. This is to ensure that CFP differs sufficiently
from usual care. The main clinical outcomes is a reduction in blood levels of creatinine, which is a marker of the severity of kidney injury.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes
Not applicable

Contacts
Principal investigator
Name 115590 0
Dr Kyle White
Address 115590 0
Intensive Care Unit
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, QLD
4102
Country 115590 0
Australia
Phone 115590 0
+61 731764650
Fax 115590 0
Email 115590 0
kyle.white@health.qld.gov.au
Contact person for public queries
Name 115591 0
Dr Kyle White
Address 115591 0
Intensive Care Unit
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, QLD
4102
Country 115591 0
Australia
Phone 115591 0
+61 731762111
Fax 115591 0
Email 115591 0
kyle.white@health.qld.gov.au
Contact person for scientific queries
Name 115592 0
Dr Kyle White
Address 115592 0
Intensive Care Unit
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, QLD
4102
Country 115592 0
Australia
Phone 115592 0
+61 731762111
Fax 115592 0
Email 115592 0
kyle.white@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review
committee (“learned intermediary”) identified for this purpose
Available for what types of analyses?
For individual participant data meta-analysis
How or where can data be obtained?
Proposals may be submitted up to 36 months following article publication to trial contact, Dr Kyle White at Kyle.white@health.qld.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14114Study protocolnot applicable kyle.white@health.qld.gov.au 383133-(Uploaded-16-11-2021-10-33-24)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.