| CTRI Number |
CTRI/2022/02/040415 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of effects of acute kidney injury in patients undergoing emergency laparotomy under general anesthesia |
|
Scientific Title of Study
|
Extent and implications of acute kidney injury in patients undergoing emergency laparotomy under general anesthesia-An 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 Beeraling Ningappa Walikar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Dr Beeraling Ningappa Walikar
Department OF Anesthesiology
AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8088864390 |
| Fax |
|
| Email |
veer1907@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Singla |
| Designation |
Associate Professor |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Dr Deepak Singla
Department OF Anesthesiology
AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9068504999 |
| Fax |
|
| Email |
deepak10.4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beeraling Ningappa Walikar |
| Designation |
Junior Resident |
| Affiliation |
AIIMS , Rishikesh |
| Address |
Dr Beeraling Ningappa Walikar
Department OF Anesthesiology
AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8088864390 |
| Fax |
|
| Email |
veer1907@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS RISHIKESH
Virbhadra Road Shivaji Nagar,near barrage,Sturida colony,Rishikesh,uttarakhand,249203 |
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
Virbhadra Road Shivaji Nagar,near barrage,Sturida colony,Rishikesh,uttarakhand,249203 |
| 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 |
| Dr Beeraling Ningappa walikar |
All India institute of medical sciences Rishikesh |
Department of anesthesiology level 6 block A
AIIMS Rishikesh
Virbhadra road shivaji nagar near barrage sturida colony Rishikesh,Uttarakhand 249203
Dehradun
UTTARANCHAL |
8088864390
beeralingnw@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS,Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Classification -I/II/III/IV |
|
| ExclusionCriteria |
| Details |
1. Patients who are diagnosed with end stage renal disease on maintenance haemodialysis
2. Patients who have pre-operative acute renal failure [defined as clinical condition associated with rapid increase in blood urea and rising serum creatinine >3mg/dl in 24hrs prior to surgery]
3. Primary obstructive urological disease
4. Patients with left ventricular ejection fraction <45%
5. Patients who have chronic liver disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patients discharge, prolonged hospital stay |
patients discharge , prolonged hospital stay will be assessed after 14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| morbidity and mortality of the patient |
within 1 month |
|
|
Target Sample Size
|
Total Sample Size="302"
Sample Size from India="302"
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)
|
02/03/2022 |
| 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="10" |
|
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)?
Response - NO
|
|
Brief Summary
|
This
study is a single institution, Observational follow up study to assess
incidence of acute kidney injury (KDIGO stage 1 and higher) in patients
undergoing emergency laparotomy under general anaesthesia (within first 7 days)
will be conducted in AIIMS Rishikesh. We hypothesized that acute kidney injury
following emergency laparotomy is same in all age groups and there is no gender
based differences. Primary outcome is to know number patients discharged and
prolonged hospital stay after acute kidney injury after emergency laparotomy
.Secondary outcomes will be morbidity, mortality due to AKI after emergency laparotomy.
|