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Ascites Hepatic clinical trials

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NCT ID: NCT06256432 Recruiting - Acute Kidney Injury Clinical Trials

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Start date: April 17, 2024
Phase: Phase 2
Study type: Interventional

Patients with advanced cirrhosis of the liver develop kidney problems occasionally. This condition is called Hepatorenal Syndrome, requires hospitalization and frequently results in death. The goal of this clinical trial is to test whether the administration of low doses of ambrisentan can help patients with Hepatorenal Syndrome and to determine if it is safe. Ambrisentan is a drug that is approved for the treatment of high blood pressure in the lungs at higher doses. This clinical trial will compare the safety and effects of ambrisentan to another drug called terlipressin, which is commonly used to treat patients with hepatorenal syndrome. The main questions the clinical trial aims to answer are: - Does ambrisentan help the kidney function of the patient? - Does ambrisentan help prevent death in patients with Hepatorenal Syndrome? - Does ambrisentan prevent Hepatorenal Syndrome from reappearing? While in the hospital, trial participants will receive either one of two doses of ambrisentan or terlipressin. If in the first 4 days, ambrisentan is not helpful, the patient may be eligible to receive terlipressin. Patients assigned to receive ambrisentan will continue taking this medication at home after leaving the hospitals and until they complete 60 days of treatment.

NCT ID: NCT06224023 Recruiting - Cirrhosis, Liver Clinical Trials

Predictive Values of Presepsin Levels in ASciteS in Patients With Chronic Liver Failure

PASS
Start date: May 6, 2024
Phase:
Study type: Observational

The investigators aim to study the predictive value of presepsin in ascites in newly admitted patients with chronic liver failure.

NCT ID: NCT05999773 Recruiting - Cirrhosis, Liver Clinical Trials

SGLT-2 Inhibitors in the Treatment of Ascites

Start date: July 15, 2023
Phase:
Study type: Observational

The goal of this observational study is to test the efficacy of glyphozines (SGLT-2 inhibitors) in the control of ascites in patients with liver cirrhosis in class A6-B9, according to the Child-Pugh classification, and type 2 diabetes mellitus. The investigators will compare patients belonging to the intervention group (A), who will be given SGLT-2 inhibitors according to diabetology indications in addition to standard medical therapy for 6, with patients of the control group (B), who will, instead, continue with the standard medical therapy for 6 months. Standard medical therapy will include dietary sodium restriction, treatment with diuretics (furosemide and spironolactone), hypoglycemic therapy (metformin, insulin, or both) and other supportive care. The main questions aims of this study are: 1. Compare the efficacy and safety of a therapeutic approach based on the administration of SGLT-2 inhibitors in addition to optimal medical therapy (MRA and loop diuretic) compared to traditional diuretic therapy only, in cirrhotic patients with saline retention and diabetes. 2. Demonstrate better control of the glycemic profile in cirrhotic diabetic patients using SGLT-2 inhibitors.

NCT ID: NCT05960006 Recruiting - Liver Cirrhosis Clinical Trials

A Study to Determine Pharmacokinetic Changes of Ceftriaxone in Patients With Liver Cirrhosis

TACTILE
Start date: July 10, 2023
Phase:
Study type: Observational

The investigators designed an observational multicenter explorative in vivo study to investigate the changes in ceftriaxone pharmacokinetics in blood and ascites. The investigators will include a total of 20 patients with liver cirrhosis admitted to the ward of participating hospitals. Patients are eligible when receiving ceftriaxone and concomitantly receive paracentesis. The investigators will collect all available waste blood samples of each participant, starting from study entry up until 48 hours after the last dosing interval of ceftriaxone. The investigators will collect all available waste ascites samples of each participant up until 48 hours after the last dosing interval of ceftriaxone. Duration of the trial: The study duration is variable and depends on the duration of ceftriaxone treatment and duration of hospital admission, which both are determined by the treating physician and is not influenced by study participation. Patients will be eligible for study inclusion when patients received (a single dose of) ceftriaxone treatment and undergo paracentesis during ceftriaxone treatment. The study will end 48 hours after the last dosing interval of ceftriaxone or until hospital discharge, whichever comes first. Study timeline: The investigators expect to enrol 1-2 participants every month. The total enrolment time will thus be approximately 12 months.

NCT ID: NCT05928624 Recruiting - Portal Hypertension Clinical Trials

A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients

WATCH
Start date: September 22, 2023
Phase: N/A
Study type: Interventional

This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.

NCT ID: NCT05793983 Recruiting - Infections Clinical Trials

S100A8/A9 and Innate Immunity in Liver Disease

Start date: September 28, 2021
Phase:
Study type: Observational

This observational study evaluates the concentration of immune protein S100A8/A9 in different liver failure syndromes, its interaction with the immune system and validity as an immunotherapeutic target to improve survival in patients with advanced cirrhosis and/or acute on chronic liver failure.

NCT ID: NCT05726747 Recruiting - Ascites Hepatic Clinical Trials

QOL and Sarcopenia in Patients With Ascites

Start date: May 23, 2023
Phase:
Study type: Observational

Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies. Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites. Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.

NCT ID: NCT05490888 Recruiting - Cirrhosis, Liver Clinical Trials

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics

Start date: January 3, 2022
Phase: Phase 1
Study type: Interventional

This single and multiple ascending dose (SAD and MAD) study evaluates PHIN-214, being studied to determine the safety, tolerability, and pharmacokinetics, and establish the maximum tolerated dose of this compound in patients with Child Pugh A and B Cirrhosis.

NCT ID: NCT05346393 Recruiting - Acute Kidney Injury Clinical Trials

HRS-AKI Treatment With TIPS in Patients With Cirrhosis

Liver-HERO
Start date: November 29, 2022
Phase: N/A
Study type: Interventional

The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).

NCT ID: NCT05014594 Recruiting - Cirrhosis Clinical Trials

Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT

Start date: September 3, 2021
Phase: Phase 2
Study type: Interventional

The development of ascites is a landmark event in the natural history of cirrhosis and signifies a grim prognosis. Portal hypertension and splanchnic arterial vasodilatation are the major contributors in the development of ascites. Vasodilatation with the consequential decrease in effective circulating volume leads to the activation of sympathetic nervous system and renin angiotensin aldosterone system (RAAS), leading to antinatriuretic effects and retention of sodium and water. This results in the formation of ascites. Management of ascites primarily consists of salt restrictrion and diuretics. Liver transplant is the ultimate panacea. Dapaglifozin, a Sodium glucose linked transporter-2(SGLT-2) inhibitor, is a part of the routine armamentarium for treatment of patients with Diabetes Mellitus type-2. Its safety is well established in non-diabetic patients too where it has been shown to improve cardiovascular outcomes. The risk of hypoglycemia is negligible as its action is independent of insulin. By virtue of its natriuretic effect, it has been shown to reduce hospitalisations in patients with heart failure irrespective of the presence of diabetes. We hypothesise that a similar natriuretic effect may help in suppressing the renin-angiotensin axis with improved mobilization of ascites in patients with cirrhosis. Pharmacokinetic data on the use of Dapaglifozin suggest that there is no need for dose modification in cirrhosis. The AUC and Cmax for Dapaglifozin in Child Pugh C cirrhosis is 67% and 40%, respectively. In a recent small case series, SGLT-2 inhibitors including dapaglifozin led to improvement in fluid retention and serum sodium, without acute kidney injury or encephalopathy, in patients with cirrhosis. However, SGLT-2 inhibitors have not been evaluated in randomized controlled trials. In this pilot study, we plan to evaluate the efficacy and safety of dapaglifozin in cirrhotics patients with recurrent ascites.