Effect of Midodrine on HVPG in Advanced Chronic Liver Disease

NCT04455464 | Completed

• 1 other identifier: ILBS-Cirrhosis-33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Midodrine

EXPERIMENTAL

Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours

Drug: Midodrine Oral Tablet

Interventions

Midodrine Oral Tablet DRUG

Midodrine will be given 10 mg for one time only.

Midodrine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• age \< 18 and \> 75,
• Pregnancy,
• Splanchnic venous thrombosis,
• Hepatocellular Carcinoma,
• Hepaticencephalopathy,
• Significant cardiopulmonary disease,
• Uncontrolled diabetes,
• Hypertension,
• Intrinsic renal disease,
• Peripheral vascular disease.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Midodrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 11, 2020
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-10

Locations

IN (1)