CTRI

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CTRI Number

CTRI/2024/02/062886 [Registered on: 20/02/2024] Trial Registered Prospectively

Last Modified On:

19/02/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Study Of Clinical Profile Of Spontaneous Bacterial Peritonitis And Its Variants In Cirrhosis Of Any Etiology

Scientific Title of Study

Study Of Clinical Profile Of Spontaneous Bacterial Peritonitis And Its Variants In Cirrhosis

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Nelaturi Venkata Subba Reddy
Designation	Post graduate
Affiliation	Kasturba Medical College Manipal
Address	Department Of General Medicine Kasturba Medical College Manipal Udupi KARNATAKA 576104 India
Phone	9550222112
Fax
Email	nsubbareddy81@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ananthakrishna Shastry
Designation	Professor and Head of unit
Affiliation	Kasturba Medical College Manipal
Address	Department Of General Medicine Kasturba Medical College Manipal Udupi KARNATAKA 576104 India
Phone	9845702450
Fax
Email	ba.shastry@manipal.edu

Details of Contact Person
Public Query

Name	Dr Ananthakrishna Shastry
Designation	Professor and Head Of Unit
Affiliation	Kasturba Medical College Manipal
Address	Department Of General Medicine Kasturba Medical College Manipal Udupi KARNATAKA 576104 India
Phone	9845702450
Fax
Email	ba.shastry@manipal.edu

Source of Monetary or Material Support

Kasturba Medical College Manipal

Primary Sponsor

Name	Kasurba Medical college Manipal
Address	Kasturba Medical College Manipal Karnataka 576104
Type of Sponsor	Private medical college

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 Nelaturi Venkata Subba Reddy	Kasturba Hospital Manipal	Department Of General Medicine And Gastroenterology Manipal Udupi KARNATAKA	9550222112 nsubbareddy81@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K746\|\|Other and unspecified cirrhosis ofliver,

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	Spontaneous bacterial peritonitis diagnosed by standard methods in cirrhotic of any etiology

ExclusionCriteria

Details

1)other causes of sepsis like -
urinary tract infection
upper and lower respiratory tract infections
any other surgically treatable active infective focus
partially treated outside SBP

2)Recent antibiotics therapy for any disease

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
Study Of Clinical Feautures Risk Factors Most Common Organism Culture Sensitivity Relation To Child Pugh Score	At Presentation And Discharge

Secondary Outcome

Outcome	TimePoints
Discharge Dama Death	At Discharge

Target Sample Size

Total Sample Size="51"
Sample Size from India="51"
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)

29/02/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

29/02/2024

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
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

NEED OF STUDY

SPONTANEOUS BACTERIAL PERITONITIS IS SERIOUS LIFE THREATENING COMPLICATION IN CIRRHOSIS .IT IS IMPORTANT TO RECOGNIZE SBP EARLY IN THE COURSE OF INFECTION BECAUSE THERE IS FRAQUENTLY A VERY SHORT WINDOW OF OPPORTUNITY DURING WHICH TO INTERVENE TO ENSURE A GOOD OUTCOME .IF OPPORTUNITY IS MISSED ,SHOCK ENSUES ,FOLLOWED RAPIDLY BY MULTI ORGAN FAILURE .

SURIVAL IS UNLIKELY IN PATIENTS WHO DEVELOP SHOCK PRIOR TO INITIATION OF ANTIBIOTICS..

ONE REPORT ESTIMATED THAT SURVIVAL DECREASED BY APPROXIMATELY 8 PERECENT FOR EACH HOUR DELAY IN STARTING ANTIBIOTICS IN PATIENTS WITH SEPTIC SHOCK .ANOTHER STUDY HD SHOWN THAT DELAYED PARACENTESIS IN PATIENTS WITH SBP LEADS TO 2.7 FOLD INCREASED RISK OF DEATH ;EACH HOUR OF DELAY IN PARACENTESIS IS ASSOSCIATED WITH 3.3 PERECENT INCREASE IN INHOSPITAL MORTALITY.THESE STATISTICS SIGNIFY NEED OF CLINICAL PROFILE OF SBPWHERE EARLY DIAGNOSIS MAKES BIG DIFFERENCE IN OUTCOMES .

DESCRIPTION OF STUDY

THE STUDY IS BASED ON PROSPECTIVE COLLECTION OF DATA FROM PATIENTS ADMITTED AT KASTURBA HOSPITAL ,MANIPAL ,DIAGNOSED WITH SPONTANEOUS BACTERIAL PERITONITIS IN CIRRHOSIS OF VARIOUS ETIOLOGIES CONFIRMED WITH CLINICAL FEATURES AND LABORATORY INVESTIGATIONS MEETING INCLUSION AND EXCLUSION CRITERIA AS MENTIONED ABOVE DURING STUDY PERIOD IN DEPARTMENT OF GENERAL MEDICINE AND DEPARTMENT OF GASTROENTEROLOGY .A PROFORMA IS PREPARED WHICH INCLUDES DEMOGRAPHIC DATA ,DETAILED HISTORYCLINICAL EXAMINATION AND REQUIRED INVESTIGATIONS AVAILABLE IN HOSPITAL ,DATA WOULD BE COLLECTED AND DOCUMENTED AFTER RECEIVING AFTER RECEIVING INFORMED WRITTEN CONSENT FROM THE PATIENT/PATIENT PARTY .PATIENT WITH INCOMPLETE DATA WILL BE DROPPED OUT OF STUDY.DATA WOULD BE ANALYSED USING APPROPRIATE STATISTICAL METHODS AND RESULTS WILL BE NOTED .