| CTRI Number |
CTRI/2024/11/076479 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In patients with prolonged liver disease and taking propranolol tablets who develop bacterial infection of the liquid surrounding the stomach, we want to study how many of them will develop kidney problem and how many of them will be alive after 28 days |
|
Scientific Title of Study
|
Progressive AKI and 28-day survival in patients with cirrhosis and spontaneous bacterial peritonitis on beta blockers-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 |
Siva Krishna Sirasapalli |
| Designation |
Assistant professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
ROOM NO 1, DEPARTMENT OF MEDICAL GASTROENTEROLOGY, 4TH FLOOR, SSB BLOCK
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7382270431 |
| Fax |
|
| Email |
sirasapallisivakrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Siva Krishna Sirasapalli |
| Designation |
Assistant professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
ROOM NO 1, DEPARTMENT OF MEDICAL GASTROENTEROLOGY, 4TH FLOOR, SSB BLOCK
PONDICHERRY
605009
India |
| Phone |
7382270431 |
| Fax |
|
| Email |
sirasapallisivakrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Abdul Rajak |
| Designation |
Senior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
5422, DEPARTMENT OF MEDICAL GASTROENTEROLOGY, 4TH FLOOR, SSB BLOCK
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8500241270 |
| Fax |
|
| Email |
abdulrajaksunkesula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Intramural fund |
| Address |
JIPMER |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Abdul Rajak Sunkesula |
JIPMER |
5422, MGE DEPARTMENT, 4TH FLOOR, SSB BLOCK
Pondicherry
PONDICHERRY |
08500241270
abdulrajaksunkesula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for group1:
Patients with cirrhosis and spontaneous bacterial peritonitis who were on propranolol, admitted in the wards of Medical Gastroenterology and Medicine during the study period.
Inclusion criteria for group2:
Patients with cirrhosis and spontaneous bacterial peritonitis who were not on propranolol, admitted in the wards of Medical Gastroenterology and Medicine during the study period. |
|
| ExclusionCriteria |
| Details |
Patients who already received antibiotic within 7days of diagnosis of SBP
Variceal bleed within 7days of diagnosis of SBP
Chronic kidney disease
Intrinsic renal disease
Refractory ascites
Hepatocellular carcinoma
Peritoneal carcinomatosis
Peritoneal tuberculosis
Pancreatitis
Bleeding into ascitic fluid
Heart Failure
Concurrent other malignancies
Human immunodeficiency virus infection
Use of immunosuppressive agents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the frequency of progressive AKI and 28-day survival in those patients with cirrhosis and spontaneous bacterial peritonitis, who are receiving beta blockers. |
2,7 and 28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the frequency of progressive AKI and 28-day survival in patients with cirrhosis and spontaneous bacterial peritonitis on beta-blockers when compared to controls. |
2,7 and 28days |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
14/11/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abdulrajaksunkesula@gmail.com].
- For how long will this data be available start date provided 24-01-2027 and end date provided 24-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Non-selective beta blockers (NSBB), when administered to patients with cirrhosis, lower portal pressure and significantly reduce the risk of esophageal variceal bleeding. They also prevent the development of ascites in patients with compensated cirrhosis and clinically significant portal hypertension. However, their role in spontaneous bacterial peritonitis (SBP) is controversial. SBP is associated with reduced effective arterial blood volume; thus, 33 to 43 percent of patients with SBP have acute kidney injury at presentation. Mortality is six times higher in patients with SBP with AKI compared to those without AKI. Twelve percent of patients with SBP had progressive AKI within 48hr after diagnosis. High serum creatinine levels before SBP diagnosis and infection resolution are independent predictors of renal impairment. In patients with SBP and mean arterial blood pressure (MAP) <65 mmHg, treatment with NSBB is associated with renal impairment. To the best of our knowledge, there is a deficit in the literature on the frequency of progressive AKI in patients with SBP who were receiving beta blockers. Studies were retrospective, with conflicting results regarding the effect of NSBB on the risk of progressive AKI and 28-day survival in patients with SBP and MAP >65 mm Hg. Hence, we are planning a prospective study to answer these questions. The primary purpose is to study the frequency of progressive AKI and 28-day survival in those patients with cirrhosis and spontaneous bacterial peritonitis, who are receiving beta blockers. |