| CTRI Number |
CTRI/2025/11/097097 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective cohort |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the proportion of patients developing kidney problems after major abdominal cancer surgeries
|
|
Scientific Title of Study
|
Incidence and Long term impact of postoperative Acute Kidney Injury in patients undergoing major abdominal surgery (IMPACT PO-AKI) |
| Trial Acronym |
IMPACT POAKI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 5010_Version 1.0 dated 10.09.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
| Phone |
02241770004042 |
| Fax |
|
| Email |
vandanachaukar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vandana Agarwal |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
| Phone |
02241770004042 |
| Fax |
|
| Email |
vandanachaukar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gajanan Vaidya |
| Designation |
Resident Doctor |
| Affiliation |
Tata Memorial Centre, Mumbai |
| Address |
Department of Anaesthesia,Critical care and pain, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai MAHARASHTRA 400012 India |
| Phone |
9561991959 |
| Fax |
|
| Email |
gajananvaidya181@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,
Parel, Mumbai-400012, India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr Ernest Borges Road, East Parel, 400012 |
| 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 Vandana Agarwal |
Tata Memorial Centre, Mumbai |
Tata Memorial Centre, Mumbai, Ernest Borges Road, Parel East, Mumbai-400012 Mumbai MAHARASHTRA |
02241770004042
vandanachaukar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital_Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting patients more than 18 years of age, undergoing elective major abdominal surgeries including Liver, pancreatic, cytoreductive surgery with or without HIPEC.
2. Patients undergoing open, laparoscopic, laparoscopic-assisted, laparoscopic converted and robotic procedures.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to consent
2. Patients undergoing surgical procedures other than those mentioned above
3. Patients undergoing planned or unplanned nephrectomy
4. Patients with pre-existing renal disease (previous history of AKI according to KDIGO criteria)
5. Post kidney transplant patient
6. Patients with end stage kidney disease on dialysis.
7. Renal replacement therapy (any form of dialysis) within the 90 days preceding the operation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of PO-AKI (an acute alteration in kidney function) within 7 days in patients undergoing major abdominal surgery including, Hepatic resection, Pancreatic surgery, cytoreductive surgery with or without HIPEC |
Within first 7 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Incidence of Early PO-AKI ( AKI occurring within 48 hrs after surgery)
2. Incidence of AKD (a sustained alteration in kidney function over a 3-month period i.e. persisting after 7 days until 3 months after surgery)
3. Incidence of CKD (a sustained alteration in kidney function persisting beyond 3 months)
4. Long term impact of PO-AKI on kidney function at first follow up visit within 3 month after discharge, 6 months and 1 year with serum creatinine value
5. Identify factors associated with PO-AKI.
6. Association between PO-AKI and postoperative length of stay
7. Need for CRRT/ dialysis during hospital stay and until one year
8. Need for reduction/omission of chemotherapeutic drugs in postoperative chemotherapy due impaired renal function.
|
at 48 hours, at the time of discharge (within 72 hours of discharge) and at 3, 6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="174" Sample Size from India="174"
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)
|
10/11/2025 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative acute kidney injury (PO-AKI) is a common complication of major surgery that is strongly associated with short-term surgical complications and long-term adverse outcomes, including increased risk of chronic kidney disease cardiovascular events and death. POAKI is best defined as AKI occurring within 7 days of an operative intervention using the Kidney Disease Improving Global Outcomes (KDIGO) definition of AKI. Prevention of PO-AKI is largely based on identification of high baseline risk, monitoring and reduction of nephrotoxic insults, whereas treatment involves the application of a bundle of interventions to avoid secondary kidney injury and mitigate the severity of AKI. Acute Kidney injury (AKI) is described as an abrupt and reversible decline in the glomerular filtration rate (GFR) which results in an elevation of serum blood urea nitrogen (BUN), creatinine and other metabolic waste products that are normally excreted by the kidney. In 2012, Kidney Disease Improving Global Outcomes (KDIGO) described the KDIGO AKI diagnostic criteria and categorized AKI into stages 1–3, determined by changes in serum creatinine and/or urine output.
The risk of developing AKI following emergency major abdominal surgery is 17percent. The risk of renal injury is particularly high in patients treated with cisplatin-containing HIPEC regimens . Incidence of AKI in patients undergoing laparoscopic pancreas surgeries was 11percent . Incidence of PO-AKI in TMH patients undergoing major abdominal cancer surgery was 10percent. Colloids have been associated with acute kidney injury. Recently, there has been a change in departmental fluid policy i.e. no use of colloids in the perioperative period, therefore we planned this prospective observational study was to study the incidence of PO-AKI. |