| CTRI Number |
CTRI/2021/02/031198 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
23/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To identify what is the frequency, underlying risks and how is outcome of kidney problems in patients undergoing open abdominal surgery on emergency basis |
|
Scientific Title of Study
|
Incidence, risk factors and outcome of acute kidney injury in adult patients undergoing Emergency Laparotomy: 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 |
Dalim Kumar Baidya |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
5th Floor, Teaching Block, All India Institute of Medical Sciences New Delhi
South West
DELHI
110029
India |
| Phone |
9871568534 |
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dalim Kumar Baidya |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
5th Floor, Teaching Block, All India Institute of Medical Sciences New Delhi
South West
DELHI
110029
India |
| Phone |
9871568534 |
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Priya |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
5th Floor, Teaching Block, All India Institute of Medical Sciences New Delhi
South West
DELHI
110029
India |
| Phone |
8940334917 |
| Fax |
|
| Email |
priya.pallavi9911@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Ansari Nagar East, New Delhi, Delhi, India |
| 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 |
| Dalim Kumar Baidya |
All India Institute of Medical Sciences New Delhi |
Department of Anaesthesiology, Room 5011, 5th Floor, Teaching Block, AIIMS, Ansari Nagar East, New Delhi 110029
South West
DELHI |
9871568534
dalimkumar.ab8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator agent |
No comparator agent |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex aged between 18-65 years undergoing emergency laparotomy |
|
| ExclusionCriteria |
| Details |
i) Previous history of chronic kidney disease (CKD) on renal replacement therapy.
ii) History of AKI within 1 week before surgery and being treated with renal replacement therapy.
iii) Refusal to consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acute kidney injury on postoperative day 3 |
Acute kidney injury on postoperative day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i) Incidence of Acute kidney injury on postoperative day 7
ii) To identify risk factors of AKI following emergency laparotomy.
iii) To identify in-hospital mortality, length of hospital stay and requirement of renal replacement therapy (RRT) in these patients
iv) To identify long-term adverse renal outcome at 3 months in those developing postoperative AKI |
postoperative day 7, during entire hospital stay and at 3 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="139"
Sample Size from India="139"
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)
|
15/02/2021 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aims of the study are to identify the incidence, risk factors and long-term adverse renal outcome of patients undergoing emergency laparotomy. Primary Objective: To identify the incidence of AKI on postoperative day 3 in adult patients undergoing emergency laparotomy. Secondary objectives To assess if preoperative arterial blood lactate level and lactate clearance can be used to predict 1. To identify the incidence of AKI on postoperative day 7 in adult patients undergoing emergency laparotomy. 2. To identify risk factors of AKI following emergency laparotomy. 3. To identify in-hospital mortality, length of hospital stay and requirement of renal replacement therapy (RRT) in these patients 4. To identify long-term adverse renal outcome at 3 months in those developing postoperative AKI Study design: Prospective observational study Study Setting: Single centre study in Emergency operation theatre, All India Institute of Medical Sciences, New Delhi Study population: Adult patients of either sex aged between 18 and 65 years undergoing emergency laparotomy. Exclusion criteria 1) Previous history of chronic kidney disease (CKD) on renal replacement therapy. 2) History of AKI within 1 week before surgery and being treated with renal replacement therapy. 3) Refusal to consent. Sample size: Anticipated frequency of post-operative AKI following emergency laparotomy is around 7- 20%. With a conservative estimate of 10% incidence and 5% confidence limit, n=139 patients will be required. |