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NCT05867602 · ClinicalTrials.gov registry record · Phase 2
High Dose Albumin in Refractory Ascites
A Phase 2 study of Ascites, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05867602: Recruiting Phase 2 study of Ascites, sponsored by Baylor College of Medicine.
NCT05867602 is a Phase 2 study of Ascites that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 100 participants, below the 125-participant average among 6 other Ascites trials with a reported enrollment target (20% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05867602, a Phase 2 study of Ascites, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and peripheral arterial vasodilation; and neurohumoral activation. Current management strategies include dietary sodium restriction and diuretic therapy, however, this strategy put patients at the risk of intravascular volume depletion, renal impairment, hepatic encephalopathy and hyponatremia. Moreover, around 10% of patients do not respond to this strategy (termed: diuretics resistant) with 50% of them die within 6 months. This sub-group is managed by frequent large volume paracentesis along with intravenous albumin administration and are usually considered for liver transplantation (LT) and TIPS. Nonetheless, Frequent paracentesis increases the risk of infection, bleeding, bowel perforation, paracentesis-induced circulatory dysfunction (PICD) and renal dysfunction in this sub-group of patients. The beneficial effect of human albumin might result from blood volume expansion tapering activated vasoconstrictor and sodium-retaining systems improving renal perfusion, hence regular infusion of albumin may be beneficial to prevent development of ascites and to improve survival. The positive effects of albumin are supported by previous studies; Romanelli et al, showed a significant increase in survival rate among cirrhotic patients with ascites when compared to those who did not receive albumin. Moreover, a randomized multicenter open label trial published in lancet last year, demonstrated that long term albumin administration improved 18-month survival, decreased the use of paracentesis and decrease in the incidence of cirrhosis related complications among cirrhotic patients with ascites. As of today, there's a limited use of regular high dose albumin in cirrhotic patients with ascites
Primary Outcome
Number of paracentesis/thoracentesis needed.
Conditions Studied
Interventions
- DRUG Albumin
Study Locations (1)
Texas
- Baylor St' Lukes Medical center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2026-06-25 |
| Phase | Phase 2 |
What NCT05867602 shows while recruiting
NCT05867602 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 125-participant average among 6 other Ascites trials with a reported enrollment target (20% lower).
The record links to 1 condition, with Ascites appearing as the primary indexed condition, and to 1 intervention - of which Albumin is the first listed.
NCT05867602 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05867602 about?
NCT05867602 is a clinical study titled "High Dose Albumin in Refractory Ascites". Advanced cirrhosis with complications is a serious problem imposing a heavy financial burden on health care system. Moreover, ascites is associated with increase in mortality rates among cirrhotic patients. Ascites pathogenesis is multifactorial including: portal hypertension; splanchnic and periphe...
What is the current status of trial NCT05867602?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2019-03-25. Estimated completion is 2026-06-25.
What conditions does trial NCT05867602 study?
This clinical trial studies the following conditions: Ascites.
What interventions are being tested in trial NCT05867602?
The interventions under investigation include: Albumin (DRUG).
Who is sponsoring clinical trial NCT05867602?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05867602 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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