Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.
The expected outcomes are
Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.
Secondary outcome:
1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Quantity Paracentesis | Experimental | Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days. |
|
| Large Volume Paracentesis | Active Comparator | Large Volume Paracentesis > 5 litres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| small quantity paracentesis | Procedure | Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis in both groups | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants which requires repeated paracentesis in both groups | 30 days | |
| Number of participants which requires repeated paracentesis in both groups | 60 days | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Manasa Alla, MD | Contact | 01146300000 | manasa1512@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Large Volume Paracentesis | Procedure | Large Volume Paracentesis > 5litres |
|
| Number of participants which requires for repeated paracentesis in both groups |
| 90 days |
| Number of participants with AKI : Improvement or worsening of renal functions in both groups | 30 days |
| Number of participants with AKI : Improvement or worsening of renal functions in both groups | 60 days |
| Number of participants with AKI : Improvement or worsening of renal functions in both groups | 90 days |
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 30 days |
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 60 days |
| Number of participants with Hepatic Encephalopathy in both groups | Grading of Hepatic Encephalopathy will be as per West Haven Classification (Score 1 to 4) in both groups | 90 days |
| Number of participants with Hyponatremia in both groups | 30 days |
| Number of participants with Hyponatremia in both groups | 60 days |
| Number of participants with Hyponatremia in both groups | 90 days |
| Diuretic tolerability : Dose tolerated in both groups | 30 days |
| Diuretic tolerability : Dose tolerated in both groups | 60 days |
| Diuretic tolerability : Dose tolerated in both groups | 90 days |
| Diuretic tolerability : Duration tolerated in both groups | 30 days |
| Diuretic tolerability : Duration tolerated in both groups | 60 days |
| Diuretic tolerability : Duration tolerated in both groups | 90 days |
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups | 30 days |
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups | 60 days |
| Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm in both groups | 90 days |
| Transplant free survival in both groups | 30 days |
| Transplant free survival in both groups | 60 days |
| Transplant free survival in both groups | 90 days |
| Number of participants develop adverse events associated with procedure in both groups | 30 days |
| Number of participants develop adverse events associated with procedure in both groups | 60 days |
| Number of participants develop adverse events associated with procedure in both groups | 90 days |
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 30 days |
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 60 days |
| Change in Model for End Stage Liver Disease Score in both groups | MELD Score ranges from 6 to 40 | 90 days |
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 30 days |
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 60 days |
| Change in CTP (Child-Turcotte-Pugh) Score in both groups | Child class A: < 7 points. Child class B: 7-9 points. Child class C: ≥10 points | 90 days |
| Number of patients required hospitalization between the groups | 30 days |
| Number of patients required hospitalization between the groups | 60 days |
| Number of patients required hospitalization between the groups | 90 days |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided