CTRI

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CTRI Number

CTRI/2026/04/107643 [Registered on: 06/04/2026] Trial Registered Prospectively

Last Modified On:

16/03/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Effectiveness of Hypertonic saline in edema in Nephrotic syndrome

Scientific Title of Study

Efficacy and safety of hypertonic saline with furosemide in nephrotic syndrome edema: an open-label non-inferiority randomized controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Suchitra R
Designation	Junior resident
Affiliation	Aiims Mangalagiri
Address	Room no: 2069 2nd Floor IPD block Department of Pediatrics AIIMS Mangalagiri Guntur ANDHRA PRADESH 522503 India
Phone	9361196787
Fax
Email	radhakrishnan.suchi@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Mahesh V
Designation	Assistant professor
Affiliation	Aiims Mangalagiri
Address	Room no: 2069 2nd Floor IPD block Department of Pediatrics AIIMS Mangalagiri Guntur ANDHRA PRADESH 522503 India
Phone	7411747661
Fax
Email	maheshvacharya@aiimsmangalagiri.edu.in

Details of Contact Person
Public Query

Name	Suchitra R
Designation	Junior resident
Affiliation	Aiims Mangalagiri
Address	Room no: 2069 2nd Floor IPD block Department of Pediatrics AIIMS Mangalagiri Guntur ANDHRA PRADESH 522503 India
Phone	9361196787
Fax
Email	radhakrishnan.suchi@gmail.com

Source of Monetary or Material Support

Inpatient ward Department of Pediatrics AIIMS Mangalagiri 522503 India

Primary Sponsor

Name	Suchitra R
Address	Room no: 2069 2nd Floor IPD block Department of Pediatrics AIIMS Mangalagiri 522503 India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Suchitra R	AIIMS Mangalagiri	Room no: 2069 2nd Floor IPD block Department of Pediatrics AIIMS Mangalagiri Guntur ANDHRA PRADESH	09361196787 m02jul025031@aiimsmangalagiri.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute ethics committee, AIIMS Mangalagiri	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N049\|\|Nephrotic syndrome with unspecified morphologic changes,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Albumin with furosemide	20% Albumin 1g/kg (max 100ml) infused over 4 hours followed by IV furosemide 1mg/kg immediately
Intervention	Hypertonic saline (3%NS) with furosemide	Hypertonic saline 5ml/kg (max 100ml) infused over 1 hour followed by IV Furosemide 1mg/kg

Inclusion Criteria

Age From	1.00 Year(s)
Age To	14.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Urine output (mL/kg) following administration of the Hypertonic saline plus Furosemide vs. 20% Albumin plus Furosemide	24 hours after administration of study intervention

Secondary Outcome

Outcome

TimePoints

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

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

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

06/04/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="11"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The participants will be enrolled only when we get the CTRI registration number. Both the study drugs Hypertonic saline and albumin are routinely used in pediatric ward, hence no trial related injury is expected.