Paracentesis-Induced Circulatory Dysfunction
Conditions
Keywords
Ascites, Paracentesis-Induced Circulatory Dysfunction, Paracentesis
Brief summary
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
Interventions
Midodrine hydrochloride for PICD prevention
DRUGHuman Albumin 20%
Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Consecutive patients above 18 years of age who fulfilled Asia Pacific Association of study of liver disease (APASL) criteria for ACLF and required paracentesis for moderate to tense ascites were included in the study. 2. Acute on Chronic Liver Failure (ACLF) was defined as an acute hepatic insult manifesting as jaundice (Serum bilirubin ≥ 5 mg/dL (85 micromole/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \< 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis and is associated with a high 28-day mortality -
Exclusion criteria
1. Patients with acute kidney injury defined as serum creatine of \> 0.3 mg/dl above the baseline 2. Severe cardiopulmonary disease 3. History of urinary retention 4. Pheochromocytoma 5. Thyrotoxicosis 6. Persistent and excessive supine hypertension define by systolic blood pressure \> 150 mm Hg 7. Pregnant patients 8. Unable to give informed consent were excluded from the study -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Paracentesis induced circulatory disturbance | Day 6 | Measure the value of plasma renin activity on sixth day after paracentesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost effectiveness of Midodrine versus Albumin | Day 6 | Cost effectiveness of use of Midodrine compared to Albumin |
| Hepatic Encephalopathy as measured by West-Haven criteria | Day 6 | Hepatic encephalopathy as measured by the West Haven criteria on day 6 in both midodrine and albumin groups |
| Renal outcome post paracentesis | Day 6 | Serum creatinine, serum sodium and serum potassium values on day 6 after paracentesis |
Countries
India
Outcome results
None listed