| CTRI Number |
CTRI/2019/08/020660 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
08/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of renal injury and patient outcome in ICU patients using urine albumin creatinine ratio. |
|
Scientific Title of Study
|
Urine albumin creatinine ratio as a marker for predicting acute kidney injury and patient outcome in critically ill sepsis patients – A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Ramachandran |
| Designation |
Senior Resident (ACAD) DM Critical Care Medicine |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology Pain Medicine And Critical Care , AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8547877350 |
| Fax |
|
| Email |
lakshmisree87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Maya Dehran |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology Pain Medicine And Critical Care , AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8800497195 |
| Fax |
|
| Email |
mayadehran@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Ramachandran |
| Designation |
Senior Resident (ACAD) DM Critical Care Medicine |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology Pain Medicine And Critical Care , AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8547877350 |
| Fax |
|
| Email |
lakshmisree87@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar
New Delhi
110029 |
| 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 Lakshmi Ramachandran |
All India Institute Of Medical Sciences |
Department Of Anaesthesiology Pain Medicine And Critical Care , AIIMS Ansari Nagar
New Delhi
DELHI |
8547877350
lakshmisree87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill sepsis patients of age 18yrs and above admitted to the ICU |
|
| ExclusionCriteria |
| Details |
Patients with anuria or hematuria
Pre-existing chronic kidney disease
Diabetes mellitus
Patients with documented proteinuria due to renal causes
Patients with ICU length of stay less than 24hr
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between albumin creatinine ratio (ACR) in urine and development of AKI. |
duration of ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the correlation between ACR in urine with duration of mechanical ventilation |
duration of ICU stay |
| Assess the correlation between ACR in urine with duration of vasopressors or inotropes support |
duration of ICU stay |
| Assess the correlation between ACR in urine with need for RRT |
duration of ICU stay |
| Assess the correlation between ACR in urine length of ICU stay,hospital stay |
length of ICU stay,hospital stay |
| Assess the correlation between ACR in urine with ICU mortality,30 days mortality |
30 days |
|
|
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)
|
19/08/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational study to assess the correlation between urine albumin creatinine ratio (ACR) and development of acute kidney injury in critically ill sepsis patients.The correlation of change in urine ACR measured at time of ICU admission and at 24 hrs with duration of mechanical ventilation,duration of vasopressor requirement ,need for renal replacement therapy,ICU and hospital length of stay,inhospital and 30 day mortality will also be studied. |