| CTRI Number |
CTRI/2020/09/027816 [Registered on: 15/09/2020] Trial Registered Prospectively |
| Last Modified On: |
14/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of ultrasound derived kidney index and urine and serum biomarkers in determining the type of kidney injury in patients with liver disease |
|
Scientific Title of Study
|
Role of Renal Resistive Index and Biomarkers (Urine NGAL, Serum IL6) in determining the type of Acute Kidney Injury in patients of Cirrhosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 72/07/2020/No81 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor, Department of Gastroenterology, GIPMER, New Delhi |
| Affiliation |
GIPMER |
| Address |
Room No 210, Second Floor, Academic Block, GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi, Delhi
Central
DELHI
110002
India |
| Phone |
9718599226 |
| Fax |
|
| Email |
ajaykumar.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Associate Professor, Department of Gastroenterology, GIPMER, New Delhi |
| Affiliation |
GIPMER |
| Address |
Room No 210, Second Floor, Academic Block, GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi, Delhi
DELHI
110002
India |
| Phone |
9718599226 |
| Fax |
|
| Email |
ajaykumar.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshan George |
| Designation |
DM Resident, Department of Gastroenterology, GIPMER, New Delhi |
| Affiliation |
GIPMER |
| Address |
Room No 502, Fifth Floor, New Resident Doctors Hostel (NRDH), GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi, Delhi
Central
DELHI
110002
India |
| Phone |
9718599210 |
| Fax |
|
| Email |
rshngeorge14@gmail.com |
|
|
Source of Monetary or Material Support
|
| GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Kumar |
| Address |
Room No 210, second Floor, Academic block, GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi-110002 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ajay Kumar |
G.B. Pant Institute of Postgraduate Medical Education and Research(GIPMER) |
Department of Gastroenterology, Second floor, Academic Block, GIPMER, 1 Jawahar Lal Nehru Marg, New Delhi, Delhi-110002
Central
DELHI |
9718599226
ajaykumar.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and associated Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (2) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of cirrhosis with AKI (≥ Stage IB, Serum creatinine ≥ 1.5mg/dL) |
|
| ExclusionCriteria |
| Details |
Hypertension
Diabetes Mellitus
Renovascular disease
CKD
Prior Kidney or Liver Tramsplant
Acute or Chronic Renal Replacement Therapy at the time of enrolment
Other causes of renal insufficiency like intrinsic causes of AKI other than ATN (like glomerulonephritis) or urinary Obstruction
Confirmed pregnancy
UTI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Differentiating between ATN(Acute Tubular Necrosis) and Non-ATN AKI(Acute Kidney Injury) |
3 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Differentiating between Pre-renal AKI, HRS(Hepatorenal Syndrome)-AKI, ATN-AKI |
3 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/09/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective observational single centre study comparing the diagnostic accuracy of renal resistive index, urine NGAL and serum IL-6 for differentiating the type of acute kidney injury in patients of cirrhosis with acute kidney injury, in 70 patients over 12 months. The primary outcome measure will be differentiating ATN vs Non-ATN AKI on day 3. The secondary outcome measure will be differentiating Pre Renal AKI, HRS-AKI, ATN-AKI on day 3. |