| CTRI Number |
CTRI/2025/02/080733 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Severity of Gut Injury to Predict Survival in Critically Ill Patients A Hospital Based Study |
|
Scientific Title of Study
|
ACUTE GASTROINTESTINAL INJURY GRADE AS A PREDICTOR OF ALL CAUSE MORTALITY IN CRITICALLY ILL PATIENTS IN A TERTIARY CENTRE -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 |
Suryavanshi Jha |
| Designation |
Senior Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Senior resident Department of critical care medicine King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9594503242 |
| Fax |
|
| Email |
drjhasurya29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Avinash Agrawal |
| Designation |
Head of Department |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of critical care medicine King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9838677999 |
| Fax |
|
| Email |
avinashagrawal@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Suryavanshi Jha |
| Designation |
Senior Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Senior resident Department of critical care medicine King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9594503242 |
| Fax |
|
| Email |
drjhasurya29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care Medicine King Georges Medical University Lucknow pincode 226003 India |
|
|
Primary Sponsor
|
| Name |
Suryavanshi jha |
| Address |
Senior resident Department of critical care Medicine King Georges Medical University Lucknow |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Suryavanshi Jha |
King Georges Medical University Lucknow |
5th floor Trauma centre Department of Critical care medicine .
Lucknow
UTTAR PRADESH |
9594503242
drjhasurya29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KGMU Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K904||Other malabsorption due to intolerance, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be included if they meet the following criteria
Aged 18 years or older
Admitted to the ICU and expected to stay for more than 48 hours
Provide informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they have
Pre-existing gastrointestinal conditions
Undergone major abdominal surgery within the last six months
Declined to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between Acute Gastrointestinal Injury grade and overall mortality in critically ill patients. |
patients will be assessed at baseline and after discharged or death and will be follow up upto 30 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the potential risk factors contributing to higher AGI grades & increased mortality in critically ill patients.
To evaluate the role of D lactate biomarkers in predicting the severity of AGI & its impact on mortality in critically ill patients.
To analyze the length of ICU stay & other clinical outcomes in relation to AGI grades.
|
patients will be assessed at baseline & after discharged or death & will be follow up upto 30 days & 90 days |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
21/02/2025 |
| 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="6"
Days="0" |
|
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
|
Introduction Acute gastrointestinal injury (AGI) is a significant but often under-recognized issue in critically ill patients, characterized by varying degrees of GI dysfunction, with a prevalence of 30% to 70%. The European Society of Intensive Care Medicine (ESICM) classifies AGI into four grades based on severity, aiding in standardizing assessment and management. AGI’s pathophysiology involves hypoperfusion, reperfusion injury, inflammation, and microbial translocation, leading to increased morbidity and mortality. Higher AGI grades are strongly associated with increased mortality. D-lactate, a bacterial fermentation byproduct, emerges as a potential biomarker for diagnosing and prognosticating AGI, correlating with the severity of GI dysfunction. Despite its clinical relevance, AGI remains under-diagnosed due to the lack of standardized criteria. Further research is needed to validate AGI grading, identify additional biomarkers, and establish standardized diagnostic and management protocols, thereby improving patient outcomes in ICU settings. This will be a prospective observational study conducted in the Department of Critical care medicine, King George Medical University, Lucknow, Uttar Pradesh.
|