Effect of Midodrine on HVPG in Advanced Chronic Liver Disease
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|ClinicalTrials.gov Identifier: NCT04455464|
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 23, 2020
- 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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Liver Disease||Drug: Midodrine Oral Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Midodrine on HVPG in Advanced Chronic Liver Disease - A Pilot Study|
|Actual Study Start Date :||July 11, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Midodrine will be given 10 mg for one time only. HVPG will be done at baseline and after 3 hours
Drug: Midodrine Oral Tablet
Midodrine will be given 10 mg for one time only.
- HVPG response after administration of midodrine as defined by decrease in HVPG by > 20 % from baseline or to less than equals to 12 mmHg [ Time Frame: 3 hours ]
- Change in Hepatic Venous Pressure Gradient. [ Time Frame: 3 hours ]
- Change in Systemic Vascular Resistance. [ Time Frame: 3 hours ]
- Change in Heart Rate. [ Time Frame: 3 hours ]
- Change in Cardiac Output. [ Time Frame: 3 hours ]
- Change in Blood pressure (Systolic, Diastolic and Mean). [ Time Frame: 3 hours ]
- Change in Cardiac Index. [ Time Frame: 3 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455464
|Contact: Dr Chitranshu Vashishtha, DMemail@example.com|
|Contact: Dr Ankit Bhardwaj, Masters-CTfirstname.lastname@example.org|
|Institute of Liver & Biliary Sciences||Recruiting|
|New Delhi, Delhi, India, 110070|
|Contact: Dr Chitranshu Vashishtha, DM 01146300000 email@example.com|