FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/01/061168 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Effect of Sucralfate as a prophylactic agent for stress ulcer in ICU settings 
Scientific Title of Study   A Multicentric Observational Study to Assess the Effectiveness of Stress Ulcer Prophylaxis (SUP) with Pantoprazole and/or Sucralfate in Routine Critical Care Practice Settings. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MC/SCF/23-003 Version 1.0 dated 11 Aug 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr N Balasubramanian 
Designation  Marketing Head, Fourrts 
Affiliation  Fourrts (India) Laboratories Pvt Ltd 
Address  Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam,

Chennai
TAMIL NADU
600096
India 
Phone  04443441880  
Fax    
Email  bala@fourrts.com  
 
Details of Contact Person
Scientific Query  
Name  Mr N Balasubramanian 
Designation  Marketing Head, Fourrts 
Affiliation  Fourrts (India) Laboratories Pvt Ltd 
Address  Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam,

Chennai
TAMIL NADU
600096
India 
Phone  04443441880  
Fax    
Email  bala@fourrts.com  
 
Details of Contact Person
Public Query  
Name  Mr N Balasubramanian 
Designation  Marketing Head, Fourrts 
Affiliation  Fourrts (India) Laboratories Pvt Ltd 
Address  Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam,

Chennai
TAMIL NADU
600096
India 
Phone  04443441880  
Fax    
Email  bala@fourrts.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai – 400013 
 
Primary Sponsor  
Name  Fourrts India Laboratories Pvt Ltd 
Address  Plot No-1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai-600097 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Diwakar T N  Bangalore Medical college and Hospital (victoria Hospital),  Department of Intensive Care Unit, Bangalore Medical college and Hospital (victoria Hospital), Mysore Rd, near City Market, New Tharagupet, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9844130534

dr.diwakartn@gmail.com 
Dr D P Mishra  Sparsh Hospital  Department of Critical Care, Sparsh Hospital Rd, Saheed Nagar, Bhubaneswar, Odisha 751007
Khordha
ORISSA 		 9658397636

devishreemishra1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ETHICS COMMITTEE OF BMCRI  Approved 
Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Subjects of either gender aged ≥18 years
2. Admission to ICU within 4 days of study enrollment
3. Stress ulcer prophylaxis with pantoprazole and/or sucralfate
4. Willingness to provide written informed consent
 
 
ExclusionCriteria 
Details  1. On pantoprazole and/or sucralfate within 48 hours preceding the current ICU admission
2. Known allergy, hypersensitivity, proven inefficiency, or contraindications to any of the study medications
3. Participation in another clinical trial within past 30 days
• Any other condition(s) or concomitant medication(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of subjects with overt, occult, or clinically important gastrointestinal bleeding during ICU stay
2. Proportion of subjects with nosocomial or hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP) during ICU stay
3. Proportion of subjects with Clostridium difficile infection during ICU stay 		 Day 30 or Day of Discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of ICU stay
2. Duration of stress-ulcer-free ICU stay
3. Duration of ICU stay free from mechanical ventilation or circulatory support 		 Baseline(Day1), End of study 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/01/2024 
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  
A Multicentric, Observational  trial in100 subjects in the age group of >=18years, admitted in ICU and require patoprazol and or sucralfate as prophylaxis for stress ulcer. The study will be conducted in 2 sites for a duration of up to 30days. Patients admitted in ICU and require patoprazol and or sucralfate as prophylaxis for stress ulcer will be informed about the study and asked if they wish to participate. Those participants who provide informed written consent , those data will be collected and analysed in the study. As this study is an observational study, so no intervention is there in the study. Only subject treatment details, complications, and lab investigations data will be collected from day 1 to upto 30 days of subject’s hospitalization or till subject’s discharge (whichever is earlier).
 
Close