| CTRI Number |
CTRI/2021/06/034148 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound Scan for detecting Acute kidney Injury after Perforation Peritonitis Surgery |
|
Scientific Title of Study
|
The Doppler Ultrasound Renal Resistive Index and Semi-quantitative Power Doppler Ultrasound for early detection of Acute Kidney Injury after Perforation Peritonitis Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Kumar Anand |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Pain Medicine and Critical care. Room no: 5005, Teaching block, AIIMS, South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013082271 |
| Fax |
|
| Email |
rahulanand00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Kumar Anand |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Pain Medicine and Critical care. Room no: 5005, Teaching block, AIIMS, South Delhi
New Delhi
DELHI
110029
India |
| Phone |
9013082271 |
| Fax |
|
| Email |
rahulanand00@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surendar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9311604365 |
| Fax |
|
| Email |
drsurensethu16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rahul Kumar Anand |
AIIMS, Ansari Nagar, New Delhi |
Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
New Delhi
DELHI |
9013082271
rahulanand00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for post graduate research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K658||Other peritonitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with perforation peritonitis posted for surgery coming under ASA status 1 & 2 |
|
| ExclusionCriteria |
| Details |
1) Patients refusal
2) Acute kidney injury on admission
3) Poor abdominal echogenicity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of Renal Resistive index and semi quantitative Power Doppler Ultrasound for the detection of Acute kidney injury in patients undergoing perforation peritonitis surgery |
Preoperative time plus postoperative follow up for 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relation between RRI and PDU with
1) Persistent AKI
2) Length of ICU stay
3) Days on ventilator
4) Days on Vasopressors |
Preoperative time plus postoperative follow up for 48 hours |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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="2"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Prospective Observational study to determine the efficacy of Doppler ultrasound Renal Resistive index and Power Doppler ultrasound for detecting Acute kidney injury at an early stage in patients undergoing perforation peritonitis surgery. |