| CTRI Number |
CTRI/2025/05/086782 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Understand the Role of Inferior Vena Cava Parameters to Assess Volume Load in Children with Nephrotic Syndrome. |
|
Scientific Title of Study
|
A Cross-sectional Observational Study to Evaluate the Role of Inferior Vena Cava Parameters to Assess Volume Load in Children with Nephrotic Syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajwanti K Vaswani |
| Designation |
Professor, Department of Pediatrics |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pediatrics , ward 2 Old Building , Seth G S Medical College and KEM hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820879168 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajwanti K Vaswani |
| Designation |
Professor, Department of Pediatrics |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pediatrics , ward 2 Old Building , Seth G S Medical College and KEM hospital
MAHARASHTRA
400012
India |
| Phone |
9820879168 |
| Fax |
|
| Email |
anukvaswani@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Bhojraj |
| Designation |
junior resident |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pediatrics , ward 2 Old Building , Seth G S Medical College and KEM hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9623681627 |
| Fax |
|
| Email |
shruti.bhojraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S MEdical College and KEM Hospital,
Parel Mumbai 400012
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Seth GS Medical College and K.E.M Hospital Parel Mumbai 400012 Maharashtra India |
| Type of Sponsor |
Other [nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajwanti K Vaswani |
Seth G S MEdical College and KEM Hospital |
Ward 2 , Old Building Department of Pediatrics, KEM Hospital Parel Mumbai 400012
Mumbai
MAHARASHTRA |
9820879168
anukvaswani@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC II,Seth GS Medical College and KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with nephrotic syndrome -first episode and relapse to paediatric ward and intensive care unit. |
|
| ExclusionCriteria |
| Details |
Patients whose parents refuse to give consent for the study.
Patients with acute kidney injury, chronic kidney disease due to other etiologies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the role of Inferior Vena cava Collapsibility and Inferior Vena cava Collapsibility index to assess volume status in nephrotic syndrome. |
At discharge of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
22/05/2025 |
| 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="1"
Months="0"
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
|
Study Summary Nephrotic syndrome is one of the common illnesses encountered in children,
presently with oedema, proteinuria, hyperlipidemia. History, physical findings, and laboratory tests have limited sensitivity and
specificity to assess relative intravascular volume or volume responsiveness. The
clinical determination of relative intravascular volume and prediction of response
to a volume intervention may be more difficult in hospitalized or critically ill
patients because they are frequently not in a steady state, and may have mismatch
between relative intravascular volume and blood pressure, or between
intravascular and extravascular volume. This study is aimed to understand the role of Inferior Vena Cava Parameters to
assess the volume load in children with nephrotic syndrome.
Children with nephrotic syndrome between 1 months and 12 yrs of age getting
admitted to the Paediatric wards will be included in the study. All routine blood
and urine examination results will be included in the study. Inferior Vena Cava
Parameters including Inferior Vena Cava Collapsibility and inferior vena cava
collapsibility index will be noted from available records.
The data will be collected with the help pf a predesigned proforma and analysed. The sample size is calculated according to previous years data, average 60
patients of nephrotic syndrome get admitted every year. Since the duration of the
study is 12 months and considering 10% attrition rate a sample size of 67 patients
is considered .
The expected outcome from the study - This study is expected to establish the role of Inferior Vena Cava Collapsibility
and Inferior vena cava collapsibility index to assess the volume status in patients
of nephrotic syndrome. Thus, IVC collapsibility will prove to be simple non invasive and cost effective
alternative to assess volume. |