An interventional study of Midodrine and Albumin in Liver Cirrhosis, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-15.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
The project is about evaluation of albumin and midodrine versus albumin alone in outcome of refractory ascites in patients with decompensated cirrhosis.
Cirrhosis is a leading cause of disability and mortality worldwide. Cirrhosis occurs in 50% of patients over 10 years. Decompensated cirrhosis carries a poor prognosis because the median survival time is about 2 years and it imposes a heavy burden on health care costs mainly due to the need for repeated hospital admission. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - AKI/HRS-NAKI, Hyponatremia, Grade of ascites-Refractory ascites, Sarcopenia, low Mean arterial pressure.
Post review of the literature, it is realized that there are some gap areas -
Study population All patients with decompensated cirrhosis with refractory ascites who get admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who fulfilthe inclusion criteria, exclusion criteria and provide informed consent
Stopping ruleAdverse reaction to Albumin
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SMT + Albumin + Midodrine (5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (\>75 mm and \<90).
Drug: Midodrine · Biological: Albumin · Other: Standard Medical Treatment
80grams/week for 2 weeks followed by 40gram/week + Placebo
Biological: Albumin · Other: Standard Medical Treatment · Other: Placebo
5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (\>75 mm and \<90)
80grams/week for 2 weeks followed by 40gram/week
Standard Medical Treatment
Placebo
Survival free of transplant and TIPS
Time frame: 6 months
Cumulative incidence of liver-related complications
Time frame: 3 months
Cumulative incidence of liver-related complications
Time frame: 6 months
Cumulative incidence of liver-related complications
Time frame: 12 months
Survival free of liver transplant in both groups
Time frame: 1 year
Survival free of TIPS in both groups
Time frame: 1 year
Incidence of HRS-AKD, in both groups at 1 year
Time frame: 1 year
Incidence of HRS-CKD in both groups at 1 year
Time frame: 1 year
Incidence of HRS AKI in both groups at 1 year
Time frame: 1 year
Cumulative frequency of large volume paracentesis
Time frame: 3 months
Cumulative frequency of large volume paracentesis
Time frame: 6 months
Cumulative frequency of large volume paracentesis
Time frame: 12 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Time frame: 3 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Time frame: 6 months
Improvement in fraility
AS PER MAYO FRAITITY INDEX , FRAITILY IS CLASSIFIED AS PRE FRAIL, FRAIL AND ROBUST.
Time frame: 12 months
Survival free of TIPS
Time frame: 6 months
Survival free of transplant at 6 months
Time frame: 6 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India