FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090146 [Registered on: 03/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Predicting Liver Injury in open heart Surgery using RBC distribution width: an observational study 
Scientific Title of Study   Red Cell Distribution Width as a Predictor of Liver Injury in Cardiac Surgery: A Prospective Observational Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasanta Kumar Das 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9312677007  
Fax    
Email  anaes_prasanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanta Kumar Das 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar


ORISSA
751019
India 
Phone  9312677007  
Fax    
Email  anaes_prasanta@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Prasanta Kumar Das 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Bhubaneswar, Sijua, Patrapada, Bhubaneswar


ORISSA
751019
India 
Phone  9312677007  
Fax    
Email  anaes_prasanta@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Sijua, Patrapada, Bhubaneswar,751019 
Type of Sponsor  Government medical college 
 
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 Prasanta Kumar Das  All india Institute of Medical Sciences, Bhubaneswar  All india Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar-751019
Khordha
ORISSA 		 9312677007

anaes_prasanta@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Adult patients (18 years-80 years) scheduled for elective or emergency cardiac surgery with CPB, including coronary artery bypass grafting (CABG), valve replacements, or aortic aneurysm repair.
2. Availability of preoperative and postoperative laboratory data
 
 
ExclusionCriteria 
Details  1.Patients with preexisting severe liver disease (e.g., cirrhosis, chronic hepatitis).
2.Active hematological disorders or malignancy.
3.Recent blood transfusions (within 1 month before surgery).
4.Incomplete perioperative data or follow-up.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the association between preoperative red cell distribution width (RDW) levels
and the incidence of liver injury in patients undergoing cardiac surgery with cardiopulmonary
bypass (CPB) 		 Preoperative period and everyday of postoperative period for 5 days or until discharge  
 
Secondary Outcome  
Outcome  TimePoints 
To assess postoperative changes in RDW levels and their correlation with the severity
of liver injury 		 Everyday of postoperative period for 5 days or until discharge  
To examine the relationship between RDW and systemic inflammation, oxidative stress, and nutritional deficiencies (e.g., iron, folate, and vitamin B12)  Everyday of postoperative period for 5 days or until discharge  
To analyze the impact of intraoperative variables, such as cardiopulmonary bypass
duration, aortic cross-clamp time, and intraoperative blood loss, on RDW and liver
injury outcomes 		 Everyday of postoperative period for 5 days or until discharge  
To investigate the prognostic value of RDW in predicting the following outcomes: all-cause in-hospital mortality, length of ICU and hospital stay, incidence of postoperative complications, including acute kidney injury,
sepsis, and prolonged mechanical ventilation 		 Everyday of postoperative period for 5 days or until discharge 
To explore the effect of preoperative blood transfusions on RDW levels and their
potential influence on postoperative liver injury and other complications 		 Everyday of postoperative period for 5 days or until discharge  
To determine the utility of RDW as a cost-effective biomarker for early risk
stratification and prognosis in cardiac surgery patients 		 Everyday of postoperative period for 5 days or until discharge  
 
Target Sample Size   Total Sample Size="388"
Sample Size from India="388" 
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)   01/08/2025 
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="2"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

After the approval of the institutional Ethics committee, a Prospective observational study shall be conducted in patients belonging to inclusion criteria who shall be planned for cardiac surgery. Informed consent will be taken from all patients before the study by the investigator. Data Collection: 1.Preoperative Phase: Patient Demographics: Age, sex, weight, height, and BMI. Clinical History: Co-morbidities (e.g., diabetes, hypertension), baseline liver function, and medications. Laboratory Tests : Complete blood count (including RDW) . Liver function tests (AST, ALT, total bilirubin, albumin). Nutritional markers (iron, folate, vitamin 812) 2. lntraoperative Phase: Duration of cardiopulmonary bypass and aortic cross-c lamp. lntra operative blood loss and transfusion requirements . Use of vasopressors and hemodynamic data. 3.Postoperative Phase: Daily RDW Measurements: Collected for the first S postoperative days.Liver Function Tests   (LFTs) : Repeated daily for 5 days or until discharge. Inflammatory Markers: C-reactive protein (CRP), interleukin-6 (IL-6).Outcomes : Incidence and severity of liver injury (defined as AST/ALT >2x upper limit of normal). Secondary outcomes, include renal dysfunction, sepsis, length of ICU and hospital stay, and all-cause mortality. Definitions 1.Liver Injury (LI) : Defined as an elevation of AST or ALT greater than 2 times the upper limit of normal (ULN) within the first S postoperative days . 2.Severe LI : Defined as AST/ALT >Sx ULN or in association with bilirubin >2x ULN. 3.Postoperative Complications: Acute kidney injury (AKI) based on KDIGO criteria. Prolonged mechanical ventilation (>24 hours). Sepsis as per Sepsis-3 definition.

 
Close