| CTRI Number |
CTRI/2018/02/011804 [Registered on: 09/02/2018] Trial Registered Prospectively |
| Last Modified On: |
08/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
occurence and factors causing sudden kidney damage in patients with normal kidney function in undergoing surgery in General Surgery department |
|
Scientific Title of Study
|
Incidence and Determinants of Acute Kidney Injury in Patients
with Previously Normal Renal Function Undergoing Major Surgery in General Surgery
Department. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pruthvidhar M |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Institute of Anesthesiology and critical care,JIPMER,PONDICHERRY,INDIA
Department of Anesthesiology and critical care,Jipmer,Pondicherry,India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7639889431 |
| Fax |
|
| Email |
pruthvidhar.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anusha Cherian |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
JIPMER |
| Address |
INSTITUTE OF ANESTHESIOLOGY AND CRITICAL CARE,JIPMER,PONDICHERRY,INDIA
Department of Anesthesiology and critical care,Jipmer,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789197801 |
| Fax |
|
| Email |
anushacherian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anusha Cherian |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
JIPMER |
| Address |
INSTITUTE OF ANESTHESIOLOGY AND CRITICAL CARE,JIPMER,PONDICHERRY,INDIA
Department of Anesthesiology and critical care,JIPMER,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789197801 |
| Fax |
|
| Email |
anushacherian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Jipmer |
| Address |
DEPARTMENT OF ANESTHESIOLOGY , 2ND FLOOR ,OLD BLOCK JIPMER |
| 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 |
| pruthvidher m |
JIPMER Hospital |
Department of Anesthesiology,JIPMER,Pondicherry
Pondicherry
PONDICHERRY |
7639889431
pruthvidhar.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing surgery with previously normal renal function, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult patient with age more than 18years with normal renal function preoperatively |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the incidence and risk factors for Acute kidney injury in patients with normal renal function |
48hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of AKI with length of hospital stay |
48hr |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
08/03/2018 |
| 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="0"
Months="6"
Days="2" |
|
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
|
To determine the incidence and risk factors leading to development of acute kidney injury in patients with previously normal renal function after undergoing major abdominal surgery using AKIN criteria for acute kidney injury |