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Methodology:
Consecutive patients of chronic liver disease in the Institute (admitted or coming to OPD) as per the inclusion and exclusion criteria will be studied.
Monitoring and assessment: Various parameters will be assessed during the procedure before and after 3 hours of midodrine such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2.
- Statistical Analysis: Continuous data will be represented by mean ± SD or median ± IQR. Categorical data will be represented by n = frequency (%). Categorical data will be analyzed by Chi square test or Fisher exact test as appropriate. Continuous data will be compared by using student t test or Mann Whitney test (when applicable). The change in HVPG will be analyzed by using paired t test or Wilcoxon signed rank test. The % change in the individual group will be compared to see the significance between the groups. The significance will be seen at 5%.
Expected outcome of the project: If result shows that HVPG is decreased by midodrine, then it can be used in place of beta blockers when they are contraindicated or have the potential of causing adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine Oral Tablet | Drug | Midodrine will be given 10 mg for one time only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HVPG response after administration of midodrine as defined by decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hepatic Venous Pressure Gradient. | 3 hours | |
| Change in Systemic Vascular Resistance. | 3 hours | |
| Change in Heart Rate. |
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Inclusion Criteria:
- i) CLD with grade III ascites with Na < 130 / Systolic BP < 90 / type 2 HRS(n=30 ) ii) ACLF (APASL criteria) with Na < 130 / Systolic BP < 90 / AKI (n=30)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver & Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39045811 | Derived | Vashishtha C, Bhardwaj A, Jindal A, Kumar M, Sarin SK. Effect of midodrine on HVPG in advanced chronic liver disease and acute-on-chronic liver failure-A pilot study. Liver Int. 2024 Oct;44(10):2714-2723. doi: 10.1111/liv.16033. Epub 2024 Jul 24. |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 3 hours |
| Change in Cardiac Output. | 3 hours |
| Change in Blood pressure (Systolic, Diastolic and Mean). | 3 hours |
| Change in Cardiac Index. | 3 hours |
| D000588 |
| Amines |