Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000666628
Ethics application status
Approved
Date submitted
16/06/2014
Date registered
25/06/2014
Date last updated
5/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
FLUid intervention and Renal Outcome TRIAL
in patients undergoing major surgery: an observational single-centred study (The FLURO TRIAL)
Scientific title
A single-centred prospective observational study investigating the effects of intravenous fluids on renal injury in adult patients undergoing major surgery
Secondary ID [1] 284804 0
Nil
Universal Trial Number (UTN)
U1111-1158-0770
Trial acronym
The FLURO TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Injury 292180 0
Fluid Intervention 292181 0
Chnages in plasma chloride 292182 0
Chnages in acid base status 292183 0
Condition category
Condition code
Anaesthesiology 292521 292521 0 0
Anaesthetics
Surgery 292522 292522 0 0
Other surgery
Renal and Urogenital 292603 292603 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will investigate the effects of intravenous fluid (type of fluid and amount) for adult patients undergoing major surgery (duration >2 hours and at least one overnight stay) over a 12-week period. The study will determine the association between perioperative intravenous fluids and acute kidney injury (AKI), defined by an increase in creatinine greater than 25% or 0.5 mg/dL (44 micromol/L) from baseline to peak value within the first 72-hours postoperatively.
Intervention code [1] 289661 0
Not applicable
Comparator / control treatment
There is no control group as this is a single group trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292380 0
Acute kidney injury, defined by an increase in creatinine greater than 25% or 0.5 mg/dL (44 micromol/L) from baseline to peak value
Timepoint [1] 292380 0
72-hours postoperatively
Secondary outcome [1] 308815 0
Plasma choride concentrations
Timepoint [1] 308815 0
72 hours post operatively
Secondary outcome [2] 308816 0
Plasma sodium concentrations
Timepoint [2] 308816 0
72 hours post operatively
Secondary outcome [3] 308817 0
Plasma potassium concentrations
Timepoint [3] 308817 0
72 hours post operatively
Secondary outcome [4] 308818 0
Plasma bicarbonate concentrations
Timepoint [4] 308818 0
72 hours post operatively
Secondary outcome [5] 308819 0
Type of IV fluid used
Timepoint [5] 308819 0
72 hours post operatively
Secondary outcome [6] 308820 0
Volume of IV fluid used
Timepoint [6] 308820 0
72 hours post operatively
Secondary outcome [7] 308821 0
Use of periopeartive blood products i.e red blood cells, platelets, fresh frozen plasma and cryoprecipitate
Timepoint [7] 308821 0
72 hours post operatively
Secondary outcome [8] 308822 0
Requirements for ICU
Timepoint [8] 308822 0
72 hourspost operatively
Secondary outcome [9] 308823 0
Duration of ICU stay
Timepoint [9] 308823 0
Length hopsital admission
Secondary outcome [10] 308824 0
Postoperative complications including but not restricted to
1. Pneumonia (elevated temperature with radiographic pulmonary changes)
2. Pulmonary congestion (shortness of breath with crepitations and oxygen desaturation requiring medical intervention)
3. Pulmonary oedema (radiological features of acute pulmonary oedoma requiring medical intervention)
4. Myocardial infarction (ECG changes with myocardial enzyme elevation)
5. Arrythmias (new onset atrial fibrillation or ventricular arrhythmia requiring pharmacological intervention or cardioversion)
6. Wound infection (deep incisional and organ/space surgical site infection requiring antibiotics or wound opening and/or re-exploration
7. Postoperative ileus (prolonged postoperative ileus greater than 5 days delaying hospital discharge)
8. Sepsis (surviving sepsis campaign: international guidelines definition)
9. Blood transfusion (postoperative blood loss requiring a blood transfusion)
Timepoint [10] 308824 0
Length of hopsital stay
Secondary outcome [11] 308825 0
In hospital mortality
Timepoint [11] 308825 0
Length of hospital stay

Eligibility
Key inclusion criteria
1. Adult patients greater or equal to 18 years of age
2. Elective or emergency surgery
3. Surgery duration greater or equal to 2 hours
4. Requiring at least one overnight stay
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than18 years of age
2. Liver transplantation

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A recently published open label sequential period study of chloride-liberal vs. chloride-restrictive fluid administration demonstrated a reduction in the incidence of injury and failure based on RIFLE criteria from 14% (95% CI, 11% - 16%) to 8.4% (95% CI, 6.4% - 10%); P<0.001) with the introduction of a chloride-restrictive fluid regime.

Assuming that, as we have conservatively estimated, we can study 500-600 subjects over a 12-week period, our sample size will provide more than 90% power with an alpha of 0.01 to detect a difference of this magnitude between patients treated with saline vs. patients treated with different crystalloid fluids.

The primary analyses will be unadjusted analyses in which binary outcomes will be compared using relative risks with 95% confidence intervals and chi square tests and continuous outcomes will be compared with the use of mean differences and un-paired T-tests assuming that normality assumptions are meet. If normality assumptions are not met then we plan to attempt simple data transformation, such as a logarithm transformation, and if this fails to proceed to a Mann-Whitney rank based test. Adjusted analyses will be performed using Poisson regression for binary outcomes and linear regression for continuous outcomes. Baseline covariates will include age, gender, elective vs. emergency surgery, surgical specialty of admission, type of operation, and baseline serum creatinine level. Survival times will be compared using log-rank tests and presented as Kaplan-Meier curves. Multivariable models will be developed to study the predictors of AKI and the independent association between fluid choice and renal outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2014
Actual
1/06/2014
Date of last participant enrolment
Anticipated
31/08/2014
Actual
31/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
542
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2628 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8293 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289416 0
Hospital
Name [1] 289416 0
Austin Hospital
Department of Anaestehsia and Intensive Care
Country [1] 289416 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Austin Hospital
Departments of Anaesthesia and Intensive Care
Level 2, Austin Towers,
Studley Road, Heidelberg, 3084, Victoria
Country
Australia
Secondary sponsor category [1] 288099 0
None
Name [1] 288099 0
Address [1] 288099 0
Country [1] 288099 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291175 0
Austin Health Reserach Ethics Unit
Ethics committee address [1] 291175 0
Ethics committee country [1] 291175 0
Australia
Date submitted for ethics approval [1] 291175 0
Approval date [1] 291175 0
28/04/2014
Ethics approval number [1] 291175 0
LNR/14/Austin/90

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 82 82 0 0
/AnzctrAttachments/366537-FLURO Trial Protocol March 2014.pdf

Contacts
Principal investigator
Name 49206 0
Dr Laurence Weinberg
Address 49206 0
Department of Anaesthesia, Austin Hospital, Studley road, Heidelberg, 3084, Victoria
Country 49206 0
Australia
Phone 49206 0
+61 3 94965000
Fax 49206 0
+61 3 94596421
Email 49206 0
[email protected]
Contact person for public queries
Name 49207 0
Laurence Weinberg
Address 49207 0
Department of Anaesthesia, Austin Hospital, Studley road, Heidelberg, 3084, Victoria
Country 49207 0
Australia
Phone 49207 0
+61 3 94965000
Fax 49207 0
+61 3 94596421
Email 49207 0
[email protected]
Contact person for scientific queries
Name 49208 0
Laurence Weinberg
Address 49208 0
Department of Anaesthesia, Austin Hospital, Studley road, Heidelberg, 3084, Victoria
Country 49208 0
Australia
Phone 49208 0
+61 3 94965000
Fax 49208 0
+61 3 94596421
Email 49208 0
[email protected]

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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