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NCT06245590
Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.
NA trial testing Albumin in Decompensated Cirrhosis in 100 participants. Status unknown.
31 January 2025
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 10 February 2024 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 2 locations across India |
Drugs / interventions tested
Conditions studied
- Decompensated Cirrhosis — all drugs for Decompensated Cirrhosis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 70, any sex, with Decompensated Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The project is about evaluation of albumin and midodrine versus midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis. Cirrhosis occcurs in 50% of patients over 10 years. 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 - acute kidney injury, hepatorenal syndrome, hyponatremia, grade of ascites-recurrent ascites, sarcopenia, low mean arterial pressure. Post review of the literature, it is realized that there are some gap areas - * It is unknown whether combination of vasoconstrictor with albumin versus vasoconstrictor alone is superior for ascites resolution in patients with recurrent ascites. * There are no studies till date on using combination of vasoconstrictor with albumin versus vasoconstrictor alone in patients with recurrent ascites. * There are no studies on impact of combining vasoconstrictor and albumin in preventing the development of AKI and chronic kidney disease in these patients. In an effort to bridge these gap areas, this project works on the following hypothesis - "Midodrine would have a synergistic effect with albumin in improving the systemic hemodynamics and circulatory dysfunction and will cause rapid control of ascites, reduce the incidence of large volume paracentesis (LVP), complications, reduce the incidence of chronic kidney disease (HRS-CKD) and improve outcome of patients with recurrent ascites in patients with decompensated cirrhosis as compared to midodrine alone" Primary objective: To assess the effect of midodrine alone vs. a combination of midodrine and albumin on the survival free of TIPS and liver transplant at 6 months Secondary objective: The effect of midodrine alone vs. combination of midodrine and albumin on the cumulative frequency of therapeutic paracentesis at 6 and 12 months Proportion of patients achieving control of ascites at 6 and 12 months
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06245590
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Related trials
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- NCT06809088 — Comparison of Safety and Efficacy of Tailored Versus Fixed Dose Albumin for the Management of Patients With Cirrhosis an · NA · not yet recruiting
- NCT06654687 — Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Ce · NA · completed
Other recruiting trials for Decompensated Cirrhosis
Currently open trials in the same condition.
- NCT06823713 — RTX001 Autologous Engineered Macrophages for Liver Cirrhosis · Phase 1, PHASE2 · recruiting
- NCT05224960 — Human Umbilical Cord-derived Mesenchymal Stem Cells for Decompensated Cirrhosis (MSC-DLC-2) · Phase 2 · recruiting
- NCT06396897 — Hospital @ Home Model of Care for Cirrhosis · NA · recruiting
- NCT06374511 — Prospective Cohort Study of Complications and Outcomes in Cirrhosis · recruiting
- NCT06134544 — Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis · NA · recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06245590 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 7 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06245590.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing