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Study identifier: NCT05867602 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

High Dose Albumin in Refractory Ascites

Condition: Ascites  ·  Sponsor: Baylor College of Medicine

PhasePhase 2
Planned participants100
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 sur…

This description comes directly from the study's public registry record.

Talk to the study team

Prasun Jalal, MD  ·  8323551424  ·  jalal@bcm.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Baylor St' Lukes Medical centerHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05867602