| 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
|
|
|
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
|
|
|
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. |