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CTRI Number  CTRI/2025/07/091533 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Single Arm Study 
Public Title of Study   Elbow Ultrasound to predict mortality in abdominal sepsis patients 
Scientific Title of Study   Evaluation of the ultrasonographic assessment of brachial artery reactivity as a predictor of mortality in abdominal sepsis patients undergoing emergency laparotomy 
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 Abhijeet Kumar Raj 
Designation  PG resident 
Affiliation  ABVIMS & Dr. RML Hospital 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi

Central
DELHI
110001
India 
Phone  9097178561  
Fax    
Email  abhijeet.rockin13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anupama Gill Sharma 
Designation  Professor 
Affiliation  ABVIMS & Dr. RML Hospital 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi

Central
DELHI
110001
India 
Phone  9910038331  
Fax    
Email  dranupama.gill@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anupama Gill Sharma 
Designation  Professor 
Affiliation  ABVIMS & Dr. RML Hospital 
Address  Room no. 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr. RML Hospital, New Delhi

Central
DELHI
110001
India 
Phone  9910038331  
Fax    
Email  dranupama.gill@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001, Central Delhi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 
Abhijeet Kumar Raj  ABVIMS and Dr Ram Manohar Lohia Hospital, New Delhi  Room no. 301 3rd floor, Department of Anaesthesia ABVIMS and Dr RML Hospital, Central delhi 110001
Central
DELHI 
09097178561

abhijeet.rockin13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS, Dr RML Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K658||Other peritonitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Consecutive Patients undergoing emergency laparotomy with abdominal sepsis as study group. (qSOFA score greater than or equal to 2 with radiological or clinical evidence of abdominal sepsis)
2. Age group: 18-65 years
3. Expected ICU stay greater than 48 hours
4. ASA I, II, III (E) 
 
ExclusionCriteria 
Details  1. Pre existing Cardiac Disease, Hepatic disease, Renal disease and Peripheral vascular disease
2. History of ICU stay in last 6 months
3. Pregnant women
4. Patient with history of metabolic syndrome, malignancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Follow up regarding death of the patient from ICU admission upto 30 days  30 day 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of Ionotropic support   Till 30 days 
Duration of mechanical ventilation  Till 30 days 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="59" 
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)   03/08/2025 
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="1"
Months="5"
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  
Emergency laparotomy, particularly in cases of intra-abdominal sepsis such as perforated peritonitis, carries a high risk of morbidity and mortality despite advances in surgical and critical care management. Accurate early predictors of patient outcomes are essential to guide clinical decision-making and optimize resource allocation in these critically ill patients.
One of the key pathophysiological drivers of poor outcomes in sepsis and systemic inflammatory conditions is endothelial dysfunction, which contributes to hemodynamic instability, impaired tissue perfusion, and eventual multi-organ failure. Recognizing this, recent interest has turned toward non-invasive vascular markers that reflect endothelial health. Adult patients with suspected infection can be rapidly identified as being more likely to have poor outcomes typical of sepsis if they have at least 2 of the following clinical criteria that together constitute a new bedside clinical score termed quick SOFA (qSOFA): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.
Brachial artery reactivity (BAR)—measured through ultrasound-based assessments like Flow Mediated Dilation (FMD) and Hyperaemic Velocity (HV)—has emerged as a surrogate marker of systemic endothelial function. FMD evaluates the dilation capacity of the brachial artery following ischemia, while HV reflects the speed of blood flow recovery and is influenced by microvascular function.
While FMD has traditionally been used in cardiovascular research, its prognostic value in sepsis remains inconsistent. Conversely, recent studies have demonstrated that reduced HV is associated with increased mortality in critically ill patients with sepsis, suggesting it may be a more sensitive indicator of adverse outcomes. 
In the context of emergency laparotomy for perforation peritonitis, where rapid risk 1stratification is crucial, assessing brachial artery reactivity could serve as a valuable, bedside tool to predict mortality. This study explores the predictive utility of BAR parameters— especially HV and FMD—as potential early biomarkers for in-hospital mortality in this high risk surgical population.
 
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