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Trial registered on ANZCTR


Registration number
ACTRN12611001157965
Ethics application status
Approved
Date submitted
31/10/2011
Date registered
4/11/2011
Date last updated
18/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
High vs low urine output targets in surgical patients.
Scientific title
High vs. Low Urine Output Targets in Surgical Patients: a randomised assessor-blinded safety study.
Secondary ID [1] 273297 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
TRENAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major bowel surgery 279068 0
Condition category
Condition code
Surgery 279257 279257 0 0
Other surgery
Renal and Urogenital 279270 279270 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the first 48 hours from the start of surgery, participants undergoing elective bowel resection will have their perioperative fluid management guided by a urine output target of 0.2 ml/kg/h. If a particpant's urine output falls below this limit, they will bolused with 500mls of intravenous fluid over 15 minutes to raise their urine output above the required target. Their urine output will be checked hourly and the processed repeated should it fall below the required target.
Intervention code [1] 283644 0
Treatment: Other
Comparator / control treatment
For the first 48 hours from the start of surgery, participants undergoing elective bowel resection will have their perioperative fluid management guided by a urine output target of 0.5 ml/kg/h. If their urine output falls below this target they will be treated in the same way as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 279880 0
Urinary and plasma concentrations of biomarkers of acute renal injury
Timepoint [1] 279880 0
Day one post surgery
Secondary outcome [1] 294665 0
Renal plasma flow - using a para-aminohippurate (PAH) infusion.
Timepoint [1] 294665 0
Day one post surgery
Secondary outcome [2] 294666 0
Glomerular Filtration Rate
Timepoint [2] 294666 0
Day one post surgery
Secondary outcome [3] 294667 0
Fluid balance will be calculated using the patient clinical fluid input/output charts. In addition, patients will also be weighed daily to assess the net quantity of fluid they have retained.
Timepoint [3] 294667 0
0-48 hours from start of surgery
Secondary outcome [4] 294669 0
Plasma concentrations of renoregulatory hormones
Timepoint [4] 294669 0
0-72 hours from start of surgery
Secondary outcome [5] 294670 0
Clinical Outcomes - incidence and grade of complications. Complications will be obtained from a prospectively collected database of perioperative clinical outcomes at our institution and graded according to the Clavien-Dindo Classification of Surgical Complications.
Timepoint [5] 294670 0
Day 30 post surgery

Eligibility
Key inclusion criteria
Patients undergoing elective bowel resection
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preexisting kidney disease or damage, perioperative nephrotoxic substance administration, pre-existing hepatic failure, ASA class IV, morbid obesity, pregnant or lactating females.

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)
Potential participants will be approached at the time of their preoperative outpatient clinic. They will be given the Particiant Information Sheet and contacted after about a week to discuss the study further and decide whether they wish to be enrolled.

Participants will be randomised at the time of induction of anaesthesia. Assessors of the primary outcome will be blinded for group allocation, while the patient and clinical team cannot be blinded for logistical reasons.

Participants are randomised (allocation concealment by off-site randomisation by Macro Randomisation Module (MacroTM EDM, InferMed, London, UK) over the internet at induction of anaesthesia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The standard release of MACRO 3.0.50 (the EDC system being used) supports block randomisations to be set up for a study using stratification values. In our case, we will use renal function greater or less than 90ml/min/1.73m2 for stratification purposes.
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
Statistical methods / analysis

Recruitment
Recruitment status
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 outside Australia
Country [1] 3937 0
New Zealand
State/province [1] 3937 0

Funding & Sponsors
Funding source category [1] 284127 0
Government body
Name [1] 284127 0
Health Research Council of New Zealand
Address [1] 284127 0
PO Box 5541, Wellesley Street, Auckland, 1141
Country [1] 284127 0
New Zealand
Funding source category [2] 284128 0
Charities/Societies/Foundations
Name [2] 284128 0
Maurice and Phylis Paykel Trust
Address [2] 284128 0
PO Box 37, 760 Parnell, Auckland, 1151
Country [2] 284128 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Surgery,
Level 12 Support Building,
Auckland City Hospital,
Park Road, Grafton,
Auckland,
1010
Country
New Zealand
Secondary sponsor category [1] 269089 0
Hospital
Name [1] 269089 0
The North Shore Hospital, Waitemata District Health Board
Address [1] 269089 0
The North Shore Hospital,
Waitemata District Health Board,
124 Shakespeare Road,
Takapuna,
Auckland City,
0622
Country [1] 269089 0
New Zealand
Other collaborator category [1] 252321 0
Other Collaborative groups
Name [1] 252321 0
The Christchurch Kidney Research Group
Address [1] 252321 0
Department of Medicine,
University of Otago,
Christchurch
PO Box 4345,
Christchurch,
8140
Country [1] 252321 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272086 0
Northern X Ethics Committee, New Zealand
Ethics committee address [1] 272086 0
Private bag 92-522, Wellesley Street, Auckland, 1141
Ethics committee country [1] 272086 0
New Zealand
Date submitted for ethics approval [1] 272086 0
Approval date [1] 272086 0
28/06/2011
Ethics approval number [1] 272086 0
NTX/11/05/033

Summary
Brief summary
This is a randomised controlled trial comparing a low urine output target to a high urine output target in the context of bowel resection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33330 0
Address 33330 0
Country 33330 0
Phone 33330 0
Fax 33330 0
Email 33330 0
Contact person for public queries
Name 16577 0
Dr Jevon Puckett
Address 16577 0
Department of Surgery,
Level 12,
Support Building,
Auckland City Hospital,
Park Road,
Grafton,
Auckland,
1010.
Country 16577 0
New Zealand
Phone 16577 0
0064 21 924919
Fax 16577 0
Email 16577 0
Jevon.Puckett@Waitematadhb.govt.nz
Contact person for scientific queries
Name 7505 0
Dr Jevon Puckett
Address 7505 0
Department of Surgery,
Level 12,
Support Building,
Auckland City Hospital,
Park Road,
Grafton,
Auckland,
1010.
Country 7505 0
New Zealand
Phone 7505 0
0064 21 924919
Fax 7505 0
Email 7505 0
Jevon.Puckett@Waitematadhb.govt.nz

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