Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000145606
Ethics application status
Approved
Date submitted
20/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of frusemide alone and frusemide and Indapamide on sodium excretion and balance in fluid overloaded Intensive Care Unit (ICU) patients
Scientific title
Comparison of frusemide alone and frusemide and Indapamide on sodium excretion and balance in fluid overloaded Intensive Care Unit (ICU) patients.
Secondary ID [1] 283878 0
NIL
Universal Trial Number (UTN)
U1111-1151-9785
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sodium excretion and balance in fluid overloaded patients 290863 0
Condition category
Condition code
Renal and Urogenital 291222 291222 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effects of orally administered as once only dose of frusemide (0.5-1mg/kg) with indapamide (5mg) on 24 hours urinary sodium excretion in ICU patients with fluid overload
Intervention code [1] 288553 0
Treatment: Drugs
Comparator / control treatment
Effects of orally administered as once only dose of frusemide (0.5-1mg/kg) on 24 hours urinary sodium excretion in ICU patients with fluid overload
Control group
Active

Outcomes
Primary outcome [1] 291216 0
Compare the urinary sodium excretion in ICU patients with fluid overload treated with frusemide and frusemide with Indapamide.

Data for sodium and fluid intake for 24 hours would be collected for assessment by measuring sodium levels in bloods and urine.
Timepoint [1] 291216 0
Outcome will be assessed at 24hrs after Frusemide or Frusemide with Indapamide administration.
Secondary outcome [1] 306247 0
Bloods and urine samples will be sent for electrolytes and renal function to compare the fluid balance, urinary potassium, magnesium excretion and creatinine clearance in ICU patients with fluid overload treated with frusemide and frusemide with Indapamide.
Timepoint [1] 306247 0
Outcome will be assessed at 24hrs after Frusemide or Frusemide with Indapamide administration.

Eligibility
Key inclusion criteria
Patients with fluid overload and indwelling urine catheter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Patients on renal replacement therapy
2 Patients with other drains present (for e.g. surgical drains, chest drain)
3 Child C liver disease
4 Patients not expected to survive for next 24 hours or those not for active treatment based on the treating consultant opinion
5 Patients on regular diuretics
6 Patients with chronic renal disease with baseline Creatinine > 180 umol/L
7 Sulphonamide allergy
8 Lactose intolerant
9 Suspected or confirmed pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using computer generated random codes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Using a 2 tailed significance, with alpha of 0.05 and a power of 80% we estimate 33 patients per group are required to show a statistical difference between the groups. To allow for contingency we aim to include 40 patients in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/11/2013
Actual
4/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1979 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 7706 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 288576 0
Self funded/Unfunded
Name [1] 288576 0
Not funded
Country [1] 288576 0
Primary sponsor type
Individual
Name
Shailesh Bihari
Address
Shailesh Bihari, Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia 5042
Country
Australia
Secondary sponsor category [1] 287286 0
None
Name [1] 287286 0
Address [1] 287286 0
Country [1] 287286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290439 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 290439 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 290439 0
Australia
Date submitted for ethics approval [1] 290439 0
Approval date [1] 290439 0
26/08/2013
Ethics approval number [1] 290439 0
191.13

Summary
Brief summary
A prospective randomized clinical trial to compare the urinary sodium excretion in ICU patients with fluid overload treated with frusemide alone when compared with frusemide and Indapamide
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45422 0
Dr Shailesh Bihari
Address 45422 0
Intensive and Critical Care Unit
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia-5042
Country 45422 0
Australia
Phone 45422 0
+61 8 8204 7288
Fax 45422 0
Email 45422 0
[email protected]
Contact person for public queries
Name 45423 0
Dr Shailesh Bihari
Address 45423 0
Intensive and Critical Care Unit
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia-5042
Country 45423 0
Australia
Phone 45423 0
+61 8 8204 7288
Fax 45423 0
Email 45423 0
[email protected]
Contact person for scientific queries
Name 45424 0
Dr Shailesh Bihari
Address 45424 0
Intensive and Critical Care Unit
Flinders Medical Centre, Flinders Drive, Bedford Park, South Australia-5042
Country 45424 0
Australia
Phone 45424 0
+61 8 8204 7288
Fax 45424 0
Email 45424 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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAddition of indapamide to frusemide increases natriuresis and creatinine clearance, but not diuresis, in fluid overloaded ICU patients.2016https://dx.doi.org/10.1016/j.jcrc.2016.01.017
N.B. These documents automatically identified may not have been verified by the study sponsor.