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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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.


 
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