| CTRI Number |
CTRI/2024/07/070289 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of Urinary Biomarkers in Urine to predict Kidney problems during Pregnancy in women with Pre-Eclampsia. |
|
Scientific Title of Study
|
Urinary Biomarkers for Prediction of Pregnancy-related Acute Kidney Injury in Parturient with Pre-Eclampsia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Sharma |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Anesthesia Office
Department of Anesthesia and Intensive Care
4th floor Main OT complex
Block A Nehru Building
Postgraduate Institute Of Medical Education And Research
Sector 12 Chandigarh
Anesthesia Office
Department of Anesthesia and Intensive Care
4th floor Main OT complex
Block A Nehru Building
Postgraduate Institute Of Medical Education And Research
Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219659296 |
| Fax |
|
| Email |
sharmaapoorva261996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Singh Aditya |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Anesthesia office
Department of Anesthesia and Intensive care
4th floor,Block A,Nehru Building
Post Graduate Institute Of Medical Education and Research
Anesthesia office
Department of Anesthesia and Intensive care
4th floor, Block A, Nehru Building
Post Graduate Institute Of Medical Education and Research
Not Applicable
N/A
160012
India |
| Phone |
9914406496 |
| Fax |
|
| Email |
ashish09399@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apoorva Sharma |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Anesthesia office
Department of Anesthesia and Intensive care
4th floor,Block A,Nehru Building
Post graduate Institute of Medical Education and Research Sector 12
Chandigarh,India
nesthesia office
Department of Anesthesia and Intensive care
4th floor,Block A,Nehru Building
Post graduate Institute of Medical Education and Research Sector 12
Chandigarh,India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219659296 |
| Fax |
|
| Email |
sharmaapoorva261996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research,Chandigarh
PIN code-160012
Chandigarh,India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institue of Medical Education and Research |
| Address |
Post Graduate Institue of Medical Education and Research,Chandigarh,India
PIN code 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Apoorva Sharma |
Junior resident
Department of Anesthesia and Intensive Care
Anesthesia office,4th floor,Block A,
Nehru building
Post Graduate Institute of Medical Education and Research
Chandigarh,India
PIN code-160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva Sharma |
Nehru Hospital,Post graduate institue of Medical Education and Research |
CLR OT/Gynae ward/Maternity Ward
Department of Obstetrics and Gynaecology
3rd Floor,Block C,Nehru Hospital
Chandigarh
CHANDIGARH |
8219659296
sharmaapoorva261996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, (2) ICD-10 Condition: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant patients who are diagnosed with eclampsia, pre-eclampsia and severe eclampsia. |
|
| ExclusionCriteria |
| Details |
Pre-existing renal insufficiency(diabetes mellitus associated with renal disease)
Gestational diabetes and peripheral vascular disease
Use of nephrotoxic drugs
Pre-existing hypertension with renal disease
Refusal to participate
Inability to give informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 diagnostic performance of and best cutoff values of the urinary markers product of TIMP2 and IGFBP to differentiate between AKI and nonAKI IN preeclampsia |
At the time of admission and follow up till 48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the demographic and clinical profiles of pregnant females in AKI and non-AKI groups.
2.Serum urea & Creatinine
3.To record the severity of AKI and the requirement of RRT in the AKI group
4.To compare the length of the hospital stay and mortality in AKI and non-AKI groups
|
At the time of admission and follow up till 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
21/07/2024 |
| 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) |
Open to Recruitment |
|
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
|
To predict acute kidney injury in pre-eclampsia patients by using biomarkers TIMP2 and IGFBP7.The observational study will be conducted in PGIMER to study the diagnostic performance of and best cut-off values of the urinary markers (product of TIMP-2 and IGFBP7) to differentiate between AKI and non-AKI in preeclampsia patients. The urine sample collection for the biomarkers will be attempted within 2 hours from admission to the labour room and repeated after 24hrs and 48 hrs. The potential presence of these biomolecules will be analyzed using an enzyme-linked immunosorbent assay. |