| CTRI Number |
CTRI/2024/06/068934 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Using the Mansoura Scoring System to Predict Abdominal Infections in Liver Patients |
|
Scientific Title of Study
|
Diagnostic Performance of Mansoura Scoring System in Predicting Spontaneous Bacterial Peritonitis in Patients With Chronic Liver Disease |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8459919999 |
| Fax |
|
| Email |
kunal.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghavendra Rao S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901731924 |
| Fax |
|
| Email |
rags.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Raghavendra Rao S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine,
Kasturba Medical College,
Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901731924 |
| Fax |
|
| Email |
rags.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine, Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal Department of General Medicine |
| Address |
Kasturba Medical College, Madhav Nagar, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 Kunal Agarwal |
Kasturba Hospital, Manipal |
Medicine OPD-A, Second floor- OPD building,
Department of General Medicine, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
8459919999
kunal.kmcmpl2023@learner.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 - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K652||Spontaneous bacterial peritonitis, |
|
|
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 |
Any patient diagnosed with Spontaneous Bacterial Peritonitis (SBP) as paracentesis showing PMN ≥ 250 cells/mm3 and/or positive ascitic fluid culture |
|
| ExclusionCriteria |
| Details |
1. Patients who had received antibiotic and/or prophylaxis for SBP at least 1 month before admission
2. Patients who had other causes of ascites, for example, pancreatitis, peritoneal carcinomatosis, tuberculosis, congestive heart failure, renal diseases, or hemorrhage into ascites and/or patients with secondary peritonitis
3. Malignancy
4. Hematological diseases
5. Received antiplatelet medications atheist 1 month before their admission
6. Conditions associated with increased MPV, for example, thyroid disorders, peripheral vascular disease
7. Active hemorrhage
8. Infused with platelet or blood at least 1 month before their admission
9. Received bone marrow transplantation/chemotherapy/ radiotherapy 1 month before admission
10. Immunocompromised patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnosis of Spontaneous Bacterial Peritonitis- Correlation Between Mansoura Scoring System Vs Ascitic Fluid Analysis: Yes/no |
At 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| In-hospital Mortality During Course of Stay: Yes/no |
At 2 years |
| Development of Acute Kidney Injury: Yes/no |
At 2 years |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
07/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The study will be aimed at the diagnostic performance of Mansoura Scoring System in predicting Spontaneous Bacterial Peritonitis (SBP) in patients with chronic liver disease Objectives 1. To compare Mansoura scoring in SBP and non SBP groups. 2. To correlate Mansoura scoring with other ascitic parameters like Total counts, differential counts, protein, albumin, culture positivity, etc. in patients with decompensated liver disease cirrhosis in SBP and non SBP groups. 3. To compare individual parameters of scoring system i.e. Mean Platelet Volume, Neutrophil Lymphocyte Ratio and C Reactive Protein in SBP and non SBP groups. 4. To correlate Mansoura scoring in survival and non survival group in patients with SBP. 5. To correlate Mansoura scoring with incidence of Acute Kidney injury in SBP and non SBP groups.
|