| 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
|
|
|
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
|
|
|
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. |