Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000480987
Ethics application status
Approved
Date submitted
9/05/2011
Date registered
10/05/2011
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results provided
11/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combination of furosemide and albumin for treatment of edema in chronic kidney disease patients
Scientific title
Combination of furosemide and albumin for treatment of edema in chronic kidney disease patients
Secondary ID [1] 262127 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edema 265800 0
Condition category
Condition code
Renal and Urogenital 265956 265956 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
crossover study
treatment with furosemide 40 mg plus albumin 10 gm intravenously one time or with furosamide 40 mg intravenously alone one time and then 2 week washout period before moving onto the alternate treatment.
Intervention code [1] 264542 0
Treatment: Drugs
Comparator / control treatment
treatment with furosemide 40 mg intravenously alone one time
Control group
Active

Outcomes
Primary outcome [1] 266707 0
Volume of urine output (mL)
compare the average increment of urine out put at 6 hour and at 24 hour between 2 interventions by using pair t test
Timepoint [1] 266707 0
At 6 and 24 hour after treatment
Primary outcome [2] 266720 0
Urine sodium (mEq)
compare the average increment of urine sodium at 6 hour and at 24 hour between 2 interventions by using pair t test
Timepoint [2] 266720 0
At 6 and 24 hour after treatment
Secondary outcome [1] 276227 0
none
Timepoint [1] 276227 0
none

Eligibility
Key inclusion criteria
Stable CKD patients were defined as patients who have GFR < 60 mL/min per 1.73m2 and no fluctuation of GFR > 10% with in 2 months
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with GFR < 10 mL/min per 1.73m2, critically ill patients such as congestive heart failure, acute renal failure, shock, on respirator and previous history of furosemide usage within two week

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)
Seal opaque envelop
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/07/2010
Actual
27/07/2010
Date of last participant enrolment
Anticipated
Actual
1/11/2011
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
22
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 3580 0
Thailand
State/province [1] 3580 0

Funding & Sponsors
Funding source category [1] 265031 0
Hospital
Name [1] 265031 0
Ramathibodi research fund
Country [1] 265031 0
Thailand
Primary sponsor type
Hospital
Name
Ramathibodi research fund
Address
Ramathibodi Hospital
Rama 4 Road Bangkok Thailand
Country
Thailand
Secondary sponsor category [1] 264129 0
None
Name [1] 264129 0
Address [1] 264129 0
Country [1] 264129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267023 0
Committe on Human Rights Related to Researchs Involving Human Subjects, Ramathibodi hospital
Ethics committee address [1] 267023 0
Ethics committee country [1] 267023 0
Thailand
Date submitted for ethics approval [1] 267023 0
Approval date [1] 267023 0
27/07/2009
Ethics approval number [1] 267023 0
MURA2009/1497

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32579 0
Prof Bunyong Phakdeekitcharoen
Address 32579 0
Renal division Department of Medicine Ramathibodi Hospital Rama 4 Road Bangkok Thailand
Country 32579 0
Thailand
Phone 32579 0
+0116622011116
Fax 32579 0
662-201-1400
Email 32579 0
[email protected]
Contact person for public queries
Name 15826 0
Bunyong Phakdeekitcharoen
Address 15826 0
Renal division Department of Medicine
Ramathibodi Hospital
Rama 4 Road Bangkok Thailand
Country 15826 0
Thailand
Phone 15826 0
662-201-1116
Fax 15826 0
662-201-1400
Email 15826 0
[email protected]
Contact person for scientific queries
Name 6754 0
Bunyong Phakdeekitcharoen
Address 6754 0
Renal division Department of Medicine
Ramathibodi Hospital
Rama 4 Road Bangkok Thailand
Country 6754 0
Thailand
Phone 6754 0
662-201-1116
Fax 6754 0
662-201-1400
Email 6754 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Complete


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
No additional documents have been identified.