Effect of Midodrine on HVPG in Advanced Chronic Liver Disease

Chronic Liver Disease Clinical Trial

Official title:

Effect of Midodrine on HVPG in Advanced Chronic Liver Disease - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455464
• Other study ID #: ILBS-Cirrhosis-33
• Status: Completed
• Phase: N/A
• Start date: July 11, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: October 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. age < 18 and > 75,

2. Pregnancy,

3. Splanchnic venous thrombosis,

4. Hepatocellular Carcinoma,

5. Hepaticencephalopathy,

6. Significant cardiopulmonary disease,

7. Uncontrolled diabetes,

8. Hypertension,

9. Intrinsic renal disease,

10. Peripheral vascular disease.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Drug:
• Midodrine Oral Tablet
Midodrine will be given 10 mg for one time only.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hepatic Venous Pressure Gradient.		3 hours
Secondary	Change in Systemic Vascular Resistance.		3 hours
Secondary	Change in Heart Rate.		3 hours
Secondary	Change in Cardiac Output.		3 hours
Secondary	Change in Blood pressure (Systolic, Diastolic and Mean).		3 hours
Secondary	Change in Cardiac Index.		3 hours