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CTRI Number  CTRI/2025/02/081232 [Registered on: 24/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Challenges in Delivering Timely Sepsis Treatment Within 1 Hour and Its Impact on Critically Ill Patients  
Scientific Title of Study   An Observational study to address the Factors affecting execution of one hour bundle of sepsis management among critically ill patients and its outcome in Tertiary care hospital Udupi District 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha 
Designation  Nurse practitioner in critical care 
Affiliation  Manipal College of Nursing MAHE Manipa 
Address  Department of Medical Surgical Nursing. Manipal college of nursing, MAHE Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9591901918  
Fax    
Email  vasusherigar1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyothi Chakrabarty 
Designation  Professor and Head 
Affiliation  Manipal College of Nursing MAHE Manipal 
Address  Head of Department, Medical Surgical Nursing, Manipal College of Nursing, MAHE Manipal 4th floor,room number- 401

Udupi
KARNATAKA
576104
India 
Phone  9880078542  
Fax    
Email  jyothi.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Melita Sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing MAHE Manipal 
Address  Department of Medical Surgical Nursing, Manipal College of Nursing, MAHE Manipal 5th floor, room no- 203

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital Madhav Nagar Manipal, Karnataka state, udupi district, INDIA, 576104 
 
Primary Sponsor  
Name  Megha 
Address  Nurse Practitioner in Critical Care, Manipal College of Nursing MAHE Manipal, Karnataka state, udupi district, INDIA 576104 
Type of Sponsor  Other [self] 
 
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 Sunil R  Kasturba Hospital Manipal  Department of Critical Care Medicine and Emergency Department, Kasturba Hospital Manipal, Karnataka State 576104
Udupi
KARNATAKA 
8095800142

sunil.r@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N10||Acute pyelonephritis, (2) ICD-10 Condition: A90-A99||Arthropod-borne viral fevers and viral hemorrhagic fevers, (3) ICD-10 Condition: G00||Bacterial meningitis, not elsewhere classified, (4) ICD-10 Condition: G04||Encephalitis, myelitis and encephalomyelitis, (5) ICD-10 Condition: J09-J18||Influenza and pneumonia, (6) ICD-10 Condition: A00-A09||Intestinal infectious diseases, (7) ICD-10 Condition: L76||Intraoperative and postproceduralcomplications of skin and subcutaneous tissue, (8) ICD-10 Condition: B95||Streptococcus, Staphylococcus, andEnterococcus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients admitted to ICU and ED with symptoms and signs suggestive of an infection or fever or signs of clinical Deterioration, Patients diagnosed with sepsis on admission or during hospital stay, Adults more than 18 Years, evidence of acute organ dysfunction, Availability of medical records to assess adherence to one hour bundle of Sepsis, who are willing to give consent, who got transferred from another ward to ICU.  
 
ExclusionCriteria 
Details  Patients with Non septic critical illness, Patient with incomplete medical records or insufficient to assess adherence to the One Hour bundle, DNR OR palliative patients, Patients with language barriers. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 To assess the compliance to one hour sepsis bundle among critically ill patients diagnosed with sepsis
2. To identify the factors affecting execution of one hour bundle of sepsis management among patients with critical illness in a tertiary care hospital in Udupi district.
3. To assess the outcome of sepsis patients in relation to delaying one hour bundle practice.
 
within one hour 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   05/03/2025 
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="0"
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  

The study on the execution of the one-hour sepsis bundle in a tertiary care hospital in Udupi District is critical for several reasons. First, timely intervention in sepsis is crucial for patient outcomes, and the one-hour bundle is a globally recognized protocol aimed at reducing mortality and morbidity. However, its execution often faces challenges, particularly in resource-limited settings. Understanding these barriers in a tertiary care hospital in Udupi District can provide insights into the local healthcare system’s strengths and weaknesses. This study can identify specific factors such as resource availability, patient’s comorbidity and that impact the timely delivery of care. Additionally, it can highlight the outcomes associated with adherence to the one-hour bundle, thus emphasizing the importance of rapid intervention. The findings can inform policy changes and targeted interventions to improve sepsis management, ultimately leading to better patient outcomes and optimized resource utilization. Therefore, the researcher is interested in investigating the variables influencing the way in which critically ill patients at Kasturba Hospital execute a one-hour bundle of sepsis therapy.

 

 
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