Effect of Midodrine on HVPG in Advanced Chronic Liver Disease
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
- Primary objective: HVPG response after administration of midodrine as defined by
decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg.
- Secondary objectives: Change in HVPG, SVR, heart rate, cardiac output, cardiac index,
Blood pressure (systolic, diastolic and mean).
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.
- Study Population: Patients of advanced chronic liver disease admitted or OPD patients in
ILBS
- Study Design: A single arm interventional study
- Study Period: 6 months
- 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: age < 18 and > 75, pregnancy, splanchnic venous thrombosis, HCC, HE,
significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic
renal disease, peripheral vascular disease.
- Sample Size with justification: This is a pilot study where a total of 60 patients will
be enrolled - 30 each in the two groups.
- Intervention: HVPG will be done in these patients at baseline and then after 3 hours of
10 mg of midodrine tablets.
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%.
- Adverse Effects: same as for HVPG (mild pain / hematoma at the puncture site, transient
arrhythmias). Midodrine has got good safety profile and is used in patients of advanced
chronic liver disease.
- Stopping Rule of study: nil
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.