| CTRI Number |
CTRI/2024/04/066171 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of acute kidney injury in critically ill patients after abdominal surgery using renal resistive index by ultrasound. |
|
Scientific Title of Study
|
Doppler renal resistive index to predict risk of acute kidney injury in critically ill patients after abdominal surgery. |
| 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.Surishetty venkata sumanth |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdurjung hospital. |
| Address |
Department of Anesthesia and Intensive care,Ground floor,Main operation theatre building,Safdurjung hospital campus,Ansari nagar east,New delhi,Delhi.
East
DELHI
110029
India |
| Phone |
7799661641 |
| Fax |
|
| Email |
Sumanth3896@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Vandana Talwar |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdurjung hospital. |
| Address |
Department of Anesthesia and intensive care, Ground floor,Main operation theatre building,Safdurjung hospital campus,Ansari nagar east,New delhi,Delhi.
East
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Vandana Talwar |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and safdurjung hospital |
| Address |
Department of Anesthesia and intensive care,Ground floor,Main operation theatre building,Safdurjung hospital campus,Ansari nagar east,new delhi,Delhi.
East
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
drvandanatalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdurjung hospital,Ansari nagar east,New delhi,Delhi,110029,India. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia and Intensive CareVMMC and Safdurjung hospital |
| Address |
Department of Anesthesia and Intensive care,Main operation theatre building,VMMC and Safdurjung hospital,New delhi,Delhi,110029,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 |
| DrSurishetty Venkata Sumanth |
VMMC and safdurjung hospital |
Department of Anesthesia and Intensive care,Ground floor,Main operation theatre building,VMMC and Safdurjung hospital ,Ansari nagar east,new delhi,110029,Delhi,India.
New Delhi
DELHI |
7799661641
Sumanth3896@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R190||Intra-abdominal and pelvic swelling, mass and lump, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age greater than 18 years.
2.patients admitted in intensive care unit after abdominal surgery.
3.At risk pateints for developing post operative acute kidney injury. |
|
| ExclusionCriteria |
| Details |
1. End stage renal disease with GFR less than 30/min/1.73 m2 BSA (Body Surface Area)
2.Cirrhosis with hepato – renal syndrome
3.Obstructive acute renal failure / Renal artery stenosis
4.Patients with cardiac arrythmias or haemodynamic instability (even with vasopressors)
5.Pregnancy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the sensitivity and specificity of Doppler renal resistive index (RRI) for predicting risk of acute kidney injury in critically ill patients after abdominal surgery. |
Renal Resistive Index is measured daily from Day1 to Day 7 after admission into Intensive Care Unit after abdominal surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate RRI with eGFR.
2. To correlate RRI with 24 hour urine output.
3. To correlate RRI with mortality. |
After admission in ICU, patients will be assessed for the development of AKI in postoperative period during ICU stay. Following AKI related parameters will be recorded daily, every morning till 7th day of ICU admission or discharge from ICU or death. |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
03/05/2024 |
| 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="6"
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
|
Post operative AKI (PO-AKI) is defined as AKI onset within 7 days of surgery. PO-AKI is associated with a longer length of ICU stay, need for mechanical ventilation, higher risk of progression to chronic kidney disease (CKD) and ICU readmission rates. Doppler based renal resistive index (RRI) is a novel index derived from ultrasound scanning of interlobular or arcuate renal arteries at the cortico-medullary junction.. In general, RRI value of 0.6 is considered to be normal. RRI value above 0.7 is associated with development of high renal vascular resistance and may indicate development of AKI. Hence, this study was planned to predict the risk of AKI in critically ill patients after abdominal surgery using Doppler renal resistive index (RRI). |