Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000379516
Ethics application status
Approved
Date submitted
16/03/2015
Date registered
27/04/2015
Date last updated
27/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of fluid restriction with urea versus fluid restriction alone for inpatient management of syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Scientific title
Comparison of fluid restriction with urea versus fluid restriction alone for improving serum sodium in SIADH
Secondary ID [1] 286365 0
Nil
Universal Trial Number (UTN)
U1111-1167-8576
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syndrome of Inappropriate ADH secretion (SIADH) 294502 0
Hyponatremia 294550 0
Condition category
Condition code
Metabolic and Endocrine 294805 294805 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomised open label trial involving all medical patients admitted to North Shore Hospital from April to July 2015 with hyponatremia secondary to SIADH. Patients will be randomised to one of two management groups: Fluid restriction <800ml alone, or a combination of fluid restriction with oral urea powder (10gm oral urea powder dissolved in 200ml of water or orange jouce given three times a day). The primary end points include time to reach sodium >128, and time to hospital discharge. Once the sodium is >128mmol/L, the primary trial will end and the fluid restriction will be changed to 1000ml and urea stopped. The primary investigator will discuss the intervention (fluid restriction and urea) with the patient and family as well as nursing staff to ensure it is adhered to.
Intervention code [1] 291424 0
Treatment: Drugs
Intervention code [2] 291466 0
Treatment: Other
Comparator / control treatment
Control: Fluid restriction only (standard treatment). The patients will have a measuring jug left at their bed side to carefully measure all oral fluid intake. A sign stating "800ml fluid restriction" will be placed at each patient's bed so that other staff/family are aware of this fluid restriction. Nursing staff will be asked to carefully document all oral fluid intake on a daily basis. The fluid restriction will be changed to 1000 ml when sodium is >128mmol/L.

Treatment arm: Fluid restriction + Urea tablets
Control group
Active

Outcomes
Primary outcome [1] 294553 0
Time to reach sodium >128mmol/L (serum sodium assay taken daily)
Timepoint [1] 294553 0
Monitored from time of enrolment for up to 7 days
Primary outcome [2] 294613 0
Time to hospital discharge
Timepoint [2] 294613 0
From time of enrolment to hospital discharge
Secondary outcome [1] 313610 0
None
Timepoint [1] 313610 0
-

Eligibility
Key inclusion criteria
1. Medical patients admitted to North Shore hospital from April to July 2015
2. Acute moderate to severe hyponatremia (Na < 128) – This data will be provided daily by the biochemistry laboratory
3. Hyponatremia secondary to SIADH, as defined below
- Serum osmolality less than 280mosmol/kg
- An inappropriately elevated urine osmolality (above 100 mosmol/kg and usually above 300 mosmol/kg)
- A urine sodium concentration above 40 meq/L
- A normal serum creatinine concentration
- Normal adrenal and thyroid function
- Patient is clinically euvolemic
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hyponatremia with impaired consciousness or seizures
Chronic kidney disease stage 4-5
Liver cirrhosis
Congestive cardiac failure
Patients on diuretics

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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 6754 0
New Zealand
State/province [1] 6754 0
Auckland

Funding & Sponsors
Funding source category [1] 290934 0
Government body
Name [1] 290934 0
There is no direct funding for this study. Standard of care procedures will be funded by Waitemata DHB (WDHB).
Country [1] 290934 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital
Address
North Shore Hospital
124 Shakespeare Road
Westlake 0622
Auckland
Country
New Zealand
Secondary sponsor category [1] 289619 0
None
Name [1] 289619 0
Address [1] 289619 0
Country [1] 289619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292540 0
Health and Disability Ethics Committees (HDECs
Ethics committee address [1] 292540 0
Approved 14 April 2015
Ethics committee country [1] 292540 0
New Zealand
Date submitted for ethics approval [1] 292540 0
16/03/2015
Approval date [1] 292540 0
14/04/2015
Ethics approval number [1] 292540 0
Submission Code: NZ/1/8297015

Summary
Brief summary
Hyponatremia is the most common electrolyte disturbance encountered in the hospital setting, and is defined as serum sodium less than 135mmol/L. It is associated with an increase risk of patient mortality as well as a longer length of hospital admission. The Syndrome of Inappropriate ADH secretion (SIADH) is the most common cause of hyponatremia in hospital inpatients. Fluid restriction is widely accepted as the first line therapy for the management of hyponatremia secondary to SIADH. Other proposed treatments include urea, salt tablets and demeclocycline, however the evidence for their use is scarce and often limited to case series.

This is a prospective randomised open label trial involving all medical patients admitted to North Shore Hospital from April to July 2015 with hyponatremia secondary to SIADH. Patients will be randomised to one of two management groups: Fluid restriction <800ml alone, or a combination of fluid restriction with urea. The primary end points include time to reach sodium >128, and time to hospital discharge. Using a 2-sided alpha level of 0.05, to detect a 5mmol/L or greater difference in mean serum sodium after one day with 80% power, will require a minimum of 12 subjects per group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55818 0
Dr Sonakshi Sharma
Address 55818 0
Endocrinology Registrar
Endocrinology/Diabetes Department
North Shore Hospital
124 Shakespeare Road
Takapuna 0622
Auckland
Country 55818 0
New Zealand
Phone 55818 0
+64212688665
Fax 55818 0
Email 55818 0
[email protected]
Contact person for public queries
Name 55819 0
Dr Sonakshi Sharma
Address 55819 0
Endocrinology Registrar
Endocrinology/Diabetes Department
North Shore Hospital
124 Shakespeare Road
Takapuna 0622
Auckland
Country 55819 0
New Zealand
Phone 55819 0
+64212688665
Fax 55819 0
Email 55819 0
[email protected]
Contact person for scientific queries
Name 55820 0
Dr Sonakshi Sharma
Address 55820 0
Endocrinology Registrar
Endocrinology/Diabetes Department
North Shore Hospital
124 Shakespeare Road
Takapuna 0622
Auckland
Country 55820 0
New Zealand
Phone 55820 0
+64212688665
Fax 55820 0
Email 55820 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
No additional documents have been identified.