| CTRI Number |
CTRI/2018/02/012036 [Registered on: 21/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
studying to role of urinary neutrophil associated gelatinase biomarker as an early predictor of acute kidney injury in patients treated with antibiotic Colistin |
|
Scientific Title of Study
|
ROLE OF URINARY NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN AS EARLY BIOMARKER OF ACUTE KIDNEY INJURY IN PATIENTS TREATED WITH COLISTIN |
| Trial Acronym |
NGAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnjan Trikha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiolgy Pain medicine And critical care,
5th floor, Teaching block
AIIMS,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810977901 |
| Fax |
|
| Email |
anjantrikha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ujwal Dhundi |
| Designation |
senior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia pain medicine and critical care,
5th floor,
Academic block,
AIIMS,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9867333545 |
| Fax |
|
| Email |
drujwaldhundi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ujwal Dhundi |
| Designation |
senior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesia pain medicine and critical care,
5th floor,
Academic block,
AIIMS,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9867333545 |
| Fax |
|
| Email |
drujwaldhundi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Instistute of Medical sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
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 |
| Dr Anjan Trikha |
All India Institute of Medical Sciences |
department of anaesthesiology pain medicine and critical care,5th floor academic block
New Delhi
DELHI |
9810977901
anjantrikha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
critically ill patients , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all patients with age 18 years or more who are planned for colistin therapy |
|
| ExclusionCriteria |
| Details |
1.Refusal of consent
2.History of chronic renal disease
3.Acute kidney injury features accordingg to RIFLE criteria
4.Recent contrast dye exposure(within 5 days) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study pattern of changes in urinary neutrophil gelatinase associated lipocalin after administration of colistin
2.To compare serum creatinine and urinary neutrophil gelatinase associated lipocalin levels for prediction of acute kidney injury in patients |
At completion recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To identify factors associated for colistin induced Acute kidney injury |
At completion of recruitment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/09/2016 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All patients with written informed consent falling under our inclusion criteria will be enrolled for our study. Detailed history and thorough physical examinations of the patient will be performed. All relevant investigation report will be noted. A note will be made of medication being taken by patient particularly nephrotoxic drugs if any. The indication (culture sensitivity, site of infection and microorganism isolated, or given empirically) would be noted. If a patient is having septic shock the requirement of vasopressors and duration shock state will be noted. Urine samples will be collected before and after administration of antibiotic at 2Hr, 24Hrs,2, 3, 5 and 7 and will be measured by using the FIA8000 quantitative immunoassay analyser . Serum creatinine will be followed daily and urine output will be followed for detection of AKI. Creatinine value on the day of initiation of Colistin therapy will be considered as baseline creatinine. Acute kidney injury will be defined as per RIFLE criteria. |