None listed
Conditions
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.
Interventions
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
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.
Sponsors
North Shore Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
Hyponatremia with impaired consciousness or seizures Chronic kidney disease stage 4-5 Liver cirrhosis Congestive cardiac failure Patients on diuretics
Outcome results
None listed