| CTRI Number |
CTRI/2024/07/071699 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Early detection of Kidney failure by plasma markers in patients undergoing emergency laparotomy surgery. |
|
Scientific Title of Study
|
Evaluation of plasma microRNA-21 for Early Detection of Postoperative Acute Kidney Injury in patients undergoing exploratory laparotomy: A Prospective Observational Study. |
| 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 Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room 413, BL Taneja Block, 4th floor, Department of Anaesthesiology, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room 413, BL Taneja Block, 4th floor, Department of Anaesthesiology, Maulana Azad Medical College.
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room 413, BL Taneja Block, 4th floor, Department of Anaesthesiology, Maulana Azad Medical College.
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, Near Delhi gate , New Delhi, 110002, India. |
| Type of Sponsor |
Government medical college |
|
|
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 Sukhyanti Kerai |
Lok Nayak Hospital. |
Emergency OT, Emergency block 4th floor, Department of Anaesthesiology.
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Maulana Azad Medical College, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA) Physical Status (PS) IE & IIE |
|
| ExclusionCriteria |
| Details |
Pre-existing renal dysfunction.
Patient presenting for redo surgery or surgery due to blunt or penetrating trauma.
Patients with preoperative altered mental status, hemodynamic instability or respiratory distress. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood level of preoperative mi-RNA-21-5p and risk of post operative AKI progression. |
4 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood levels of preoperative miRNA-146-5p and risk of Postoperative AKI progression. |
4 hour after surgery |
| Association of miRNA levels and severity of AKI |
4 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
We will collecting baseline samples pre operatively from the eligible patients after obtaining written informed consent, patient will be induced as per the standard anaesthesia protocol, 4 hours after the surgery, another sample for miRNA will be obtained and the patient will be followed up on day 3 and day 7 after the surgery for the assessment and follow up for AKI |