Health Condition 1: N049- Nephrotic syndrome with unspecified morphologic changes
Conditions
Interventions
Intervention1: Hypertonic saline (3%NS) with furosemide: Hypertonic saline 5ml/kg (max 100ml) infused over 1 hour followed by IV Furosemide 1mg/kg
Control Intervention1: Albumin with furosemide: 20% A
Sponsors
Suchitra R
Eligibility
Inclusion criteria
Inclusion criteria: 1. 1 to 14 year old with nephrotic syndrome with moderate to severe edema 2. Sodium avidity evidenced by FENa less than 0.5% or urine sodium less than equal to 20mmol/l 3. eGFR more than 60ml/min/1.73m2 4. Serum albumin less than 2g/dl
Exclusion criteria
Exclusion criteria: 1. Secondary forms of nephrotic syndrome 2. Serum sodium more than 145meq/l 3. Clinical hypovolemia, pulmonary edema and congestive cardiac failure 4. Have used diuretics or albumin in the last 24 hours 5.Hypersensitivity to albumin or hypertonic saline 6.Previously included in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine output (mL/kg) following administration of the Hypertonic saline plus Furosemide vs. 20% Albumin plus FurosemideTimepoint: 24 hours after administration of study intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with adequate diuresis (urine output more than 2 ml/kg/hr) Proportion with treatment failure, defined as urine output less than 0.5ml/kg/hr for 24 hr Percentage of weight loss from baseline. Proportion of patients with significant treatment emergent adverse event requiring cessation of therapy, including moderate to severe dehydration, hypotension, any AKI Change in serum electrolytes (sodium, potassium, magnesium), uric acid, blood glucose, & estimated GFR (modified Schwartz) Natriuresis, in meq/kg/hr. & free water clearance Timepoint: Adequate diuresis 24 hours after administration of study intervention. Treatment failure 24 hours after intervention. Weight loss 24 hours after intervention. Adverse events clinically monitored continuously. Change in electrolytes & GFR at 24 hours after intervention Natriuresis & free water clearance 24 hours after intervention | — |
Countries
India
Contacts
Public ContactSuchitra R
Aiims Mangalagiri
Outcome results
None listed