sefulness of Tolvaptan tablet over Furosemide injection in reducing swelling in Nephrotic syndrome
Not Applicable
- Conditions
- Health Condition 1: N042- Nephrotic syndrome with diffuse membranous glomerulonephritisHealth Condition 2: N045- Nephrotic syndrome with diffuse mesangiocapillary glomerulonephritisHealth Condition 3: N041- Nephrotic syndrome with focal andsegmental glomerular lesionsHealth Condition 4: N040- Nephrotic syndrome with minor glomerular abnormalityHealth Condition 5: N048- Nephrotic syndrome with other morphologic changesHealth Condition 6: N049- Nephrotic syndrome with unspecified morphologic changes
- Registration Number
- CTRI/2022/10/046590
- Lead Sponsor
- Department of Pediatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Nephrotic syndrome aged between 5 and 14 years with moderate to severe edema
2) Patients not responding to oral furosemide for up to 24 hours (decrease in 3% body weight or urine output < 1 ml/kg/hour)
3) Parents willing to give informed written consent
Exclusion Criteria
1) Patients with hypovolemia
2) Patients with cerebral venous sinus thrombosis
3) Serum sodium < 125 or > 140 meq/L
4) eGFR < 60 ml/min/1.73 m2
5) SGOT/SGPT > 2 ULN
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rine output over the first 48 hours (ml/kg/hr)Timepoint: 0 hours <br/ ><br>12 hours <br/ ><br>24 hours <br/ ><br>36 hours <br/ ><br>48 hours
- Secondary Outcome Measures
Name Time Method â?¢Percentage of weight loss over 48 hours <br/ ><br> <br/ ><br>â?¢Serum sodium every 12 hourly for 48 hours <br/ ><br> <br/ ><br>â?¢Urine and serum osmolality every 24 hours for 48 hours <br/ ><br> <br/ ><br>â?¢Urine sodium/ potassium/ creatinine every 24 hours for 48 hours <br/ ><br> <br/ ><br>â?¢Adverse effects <br/ ><br>Timepoint: 0 Hours <br/ ><br>12 hours <br/ ><br>24 hours <br/ ><br>36 hours <br/ ><br>48 hours