Effect of Midodrine on HVPG in Advanced Chronic Liver Disease
- Registration Number
- NCT04455464
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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)
- age < 18 and > 75,
- Pregnancy,
- Splanchnic venous thrombosis,
- Hepatocellular Carcinoma,
- Hepaticencephalopathy,
- Significant cardiopulmonary disease,
- Uncontrolled diabetes,
- Hypertension,
- Intrinsic renal disease,
- Peripheral vascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Midodrine Midodrine Oral Tablet Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Change in Hepatic Venous Pressure Gradient. 3 hours Change in Systemic Vascular Resistance. 3 hours Change in Heart Rate. 3 hours Change in Cardiac Output. 3 hours Change in Blood pressure (Systolic, Diastolic and Mean). 3 hours Change in Cardiac Index. 3 hours
Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences
🇮🇳New Delhi, Delhi, India