| CTRI Number |
CTRI/2024/06/068360 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of New-onset Diarrhea in ICU patients. |
|
Scientific Title of Study
|
Incidence, Risk factors and Consequences of New-onset Diarrhea in Intensive care unit patients: 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 |
Kiran Kuraning |
| Designation |
DrNB superspeciality trainee, Critical care medicine department |
| Affiliation |
Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru , 560076 |
| Address |
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Bangalore
KARNATAKA
560076
India |
| Phone |
8951587113 |
| Fax |
|
| Email |
kirankuraning@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kiran Kuraning |
| Designation |
DrNB superspeciality trainee, Critical care medicine department |
| Affiliation |
Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru , 560076 |
| Address |
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Bangalore
KARNATAKA
560076
India |
| Phone |
8951587113 |
| Fax |
|
| Email |
kirankuraning@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Kuraning |
| Designation |
DrNB superspeciality trainee, Critical care medicine department |
| Affiliation |
Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru , 560076 |
| Address |
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Department of Critical Care medicine, 3rd floor
Fortis Hospital, Bannerghatta road, Opposite to IIMB, Bengaluru
Bangalore
KARNATAKA
560076
India |
| Phone |
918951587113 |
| Fax |
|
| Email |
kirankuraning@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru 560076 |
|
|
Primary Sponsor
|
| Name |
Fortis Hospital |
| Address |
Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru 560076 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Kiran Kuraning |
Fortis Hospital |
Department of critical care medicine, 3rd floor, Fortis Hospital, Bannerghatta Road, Opposite to IIMB, Bengaluru 560076
Bangalore
KARNATAKA |
8951587113
kirankuraning@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fortis Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years
2. Patients admitted to Intensive care unit for ≥ 48 hours
|
|
| ExclusionCriteria |
| Details |
1. Second and subsequent admission of same patient during study period
2. Patients with post-Gastrointestinal surgery / with colostomy
3. Patients with prior Gastrointestinal disease
4. Decompensated Chronic Liver disease (DCLD) patients with therapeutic targets of 3-4 stools /day
5. Patients with diarrhea on admission |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| (i) To estimate the incidence of new-onset diarrhea in Intensive Care Unit |
From 48 hours of ICU admission till the time patient is in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i)To assess the risk factors of diarrhea in ICU
(ii)To describe the association with pharmacological agents
(iii)To find proportion of infective diarrhea in ICU
(iv)To explore the consequences of diarrhea and associated ICU outcome
|
From 48 hours of ICU admission till the time patient is in ICU |
|
|
Target Sample Size
|
Total Sample Size="173"
Sample Size from India="173"
Final Enrollment numbers achieved (Total)= "173"
Final Enrollment numbers achieved (India)="173" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
29/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/06/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This is a prospective observational study. This study includes all the patients ≥ 18 years admitted in Medical ICU during study period satisfying the inclusion and exclusion criteria after taking informed consent. Aim of our study is to estimate the incidence of new-onset diarrhea in Medical ICU. In this study, our other objectives are to assess the risk factors of diarrhea in ICU, to describe the association with pharmacological agents, to find proportion of infective diarrhea in ICU and to explore the consequences of diarrhea and associated ICU outcome. The details will be filled as per the proforma and entered in Excel sheet. Results will be noted after statistical analysis. |