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Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in decompensated cirrhosis during large-volume paracentesis. However, it may not be cost-effective and has side effects like volume overload and transfusion reactions.
Therefore the investigator proposed to use midodrine which is a drug that increases the mean arterial pressure. The investigators hypothesized that midodrine may be effective in preventing PICD in acute on chronic liver failure patients requiring modest paracentesis. This has already been found to be effective in initial studies in decompensated cirrhosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm receiving 20% Human Albumin | Active Comparator | 20% Human albumin given intravenously over 4 hours |
|
| Arm receiving Midodrine | Experimental | Tablet Midodrine 2.5 mg - 3 tablets thrice daily orally starting just before paracentesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine Hydrochloride | Drug | Midodrine hydrochloride for PICD prevention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of Paracentesis induced circulatory disturbance | Measure the value of plasma renin activity on sixth day after paracentesis | Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness of Midodrine versus Albumin | Cost effectiveness of use of Midodrine compared to Albumin | Day 6 |
| Hepatic Encephalopathy as measured by West-Haven criteria | Hepatic encephalopathy as measured by the West Haven criteria on day 6 in both midodrine and albumin groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MITHUN SHARMA, MD FACG AGAF | Asian Institute of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad | Telangana | 500032 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34626828 | Result | Shrestha DB, Budhathoki P, Sedhai YR, Baniya R, Awal S, Yadav J, Awal L, Davis B, Kashiouris MG, Cable CA. Safety and efficacy of human serum albumin treatment in patients with cirrhotic ascites undergoing paracentesis: A systematic review and meta-analysis. Ann Hepatol. 2021 Dec;26:100547. doi: 10.1016/j.aohep.2021.100547. Epub 2021 Oct 6. | |
| 32274344 |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Human Albumin 20% |
| Drug |
Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance |
|
| Day 6 |
| Renal outcome post paracentesis | Serum creatinine, serum sodium and serum potassium values on day 6 after paracentesis | Day 6 |
| Kulkarni AV, Kumar P, Sharma M, Sowmya TR, Talukdar R, Rao PN, Reddy DN. Pathophysiology and Prevention of Paracentesis-induced Circulatory Dysfunction: A Concise Review. J Clin Transl Hepatol. 2020 Mar 28;8(1):42-48. doi: 10.14218/JCTH.2019.00048. Epub 2020 Mar 26. |
| 24100756 | Result | Bai M, Han G. Midodrine for paracentesis-induced circulatory dysfunction. J Clin Gastroenterol. 2014 Mar;48(3):300. doi: 10.1097/MCG.0b013e3182a8bfaf. No abstract available. |
| D000588 |
| Amines |