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Liver Cirrhosis clinical trials

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NCT ID: NCT05060523 Recruiting - Liver Cirrhosis Clinical Trials

To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial)

Start date: September 19, 2021
Phase: N/A
Study type: Interventional

In this randomized controlled trial , The patients who satisfy the below inclusion and exclusion criteria will be included and they will be randomised, according to 2 groups ( in total 110patients in each group) to receive either Midodrine+Tolvaptan or tolvaptan+placebo for 7 days followed by follow up for 1 month. These patients will be admitted to the hospital from OPD or emergency. In patients with cirrhosis with Patients with cirrhosis -there are two types of hyponatremia. hyponatremia is due to important losses of extracellular fluid, most commonly from the kidneys (because of overdiuresis due to treatment with excessive doses of diuretics) or from the gastrointestinal tract( hypovolemic hyponatremia) hyponatremia develops in the setting of expanded extracellular fluid volume and plasma volume with ascites and edema.This condition is known as hypervolemic or dilutional hyponatremia.A marked impairment of renal solute-free water excretion, resulting in disproportionate renal retention of water with respect to sodium retention.In SALT trail showed that tolvaptan showed improvement in Na+ concentration from baseline at 4 ,30 day. It acts on by increasing free water generation by blocking ADH receptors in distal convoluted tubule. A study by Patel et al in 2017 showed that midodrine also increasing the Na+ by increasing the free water delivery to distal convoluted tubules(in cirrhosis usually there is less water delivery to distal convoluted tubules in view of less GFR).Till now there is no study has been done as combination of midodrine and tolvaptan whether superior to tolvaptan alone or not .So our aim is to study combination of midodrine and tolvaptan verses tolvaptan alone in patients with hyponatremia.

NCT ID: NCT05059795 Recruiting - Sepsis Clinical Trials

Volume Resuscitation in Cirrhosis With Sepsis Induced Hypotension

Start date: February 1, 2020
Phase:
Study type: Observational

In critically ill patients with liver disease like cirrhosis or ACLF, fluid therapy needs to be instituted after identification of patients who will be fluid responsive and initiate appropriate inotropes early to prevent the mortality associated with fluid overload. The parameters and methodology used for assessing fluid responsiveness have been studied earlier, but the optimum method is not established. Existing recommendations based on data regarding fluid responsiveness and choice of fluid for resuscitation from intensive care units in general cannot be applied to those with liver disease as the hemodynamic alterations that occur with liver disease, presence of hypoalbuminemia at baseline and presence of cardiac dysfunction interfere with the conventional methods of fluid status assessment, fluid responsiveness as well as the response to different types of resuscitation fluids. Therefore the investigators attempt to compare various methods to estimate current intravascular volume status of patient which could be helpful in guiding fluid therapy.

NCT ID: NCT05057572 Recruiting - Liver Cirrhosis Clinical Trials

Efficacy and Safety of Carvedilol in Cirrhosis Patients With Uncomplicated Ascites Without High Risk Esophageal Varices

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The cumulative risk of refractory ascites is in the order of 20% within five years of the development of ascites. An elevated sinusoidal pressure is essential for the development of ascites, as fluid accumulation does not develop at portal pressure gradient below 8 mm Hg, and rising corrected sinusoidal pressure correlates with decreased 24-hour urinary excretion of sodium.More recently, it has been hypothesised that bacterial translocation associated with portal hypertension in cirrhosis and related pathogen-associated, molecular pattern activated innate immune responses lead to systemic inflammation.This is associated with vasodilatation as well as release of proinflammatory cytokines, reactive oxygen and nitrogen species, contributing to organ dysfunction.This activates sympathetic nervous system stimulating reabsorption of sodium in proximal,distal tubules, loop of Henle and collecting duct as well as the renin-angiotensin-aldosterone system, leading to sodium absorption from distal tubule and collecting duct.[5]Renal sodium retention and eventual free water clearance due to non-osmoticrelease of arginine-vasopressin and its action on V2 receptor in the collectingduct underlie the fluid retention associated with oedema and ascites in cirrhosis.The lowering of portal pressure using non selective beta blocker has also been shown to reduce the development of ascites, refractory ascites and hepatorenal syndrome.Furthermore, the effect of non slective beta blocker on intestinal permeability, bacterial translocation and inflammatory response has been proposed to mitigate the risk of developing spontaneous bacterial peritonitis.

NCT ID: NCT05056220 Recruiting - Clinical trials for Decompensated Cirrhosis and Ascites

Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites

Start date: February 26, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical biomarker validation trial is to test the effect of a predictive biomarker panel to human albumin infusions in patients with liver cirrhosis and ascites. The main questions it aims to answer are: - If the predictive biomarker panel can identify patients who are likely to benefit from regular human albumin infusions - If the predictive biomarker panel can lower the number-needed-to-treat of regular human albumin infusions in patients with liver cirrhosis and ascites The predictive biomarker panel will stratify patients into either a high- or low-expected effect of human albumin infusions. Hereafter are participants randomized into treatment arms. Participants in the active treatment arm will receive regular human albumin infusions during a course of 6 months. Infusions will occur every 10th day for the duration of the study. Researchers will compare 20% human albumin infusions with regular 0.9% sodium chloride to identify the effects on the number of liver-related events.

NCT ID: NCT05045482 Recruiting - Cirrhosis Clinical Trials

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Start date: October 21, 2021
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

NCT ID: NCT05028829 Recruiting - Cirrhosis Clinical Trials

Safety and Efficacy of Atorvastatin v. Placebo on HCC Risk

TORCH
Start date: May 10, 2023
Phase: Phase 2
Study type: Interventional

Prospective randomized, multi-center, double blind placebo-controlled trial to assess the chemopreventive impact of atorvastatin (20 mg oral) vs placebo in up to 60 adults with advanced fibrosis at high risk of developing HCC.

NCT ID: NCT05021406 Recruiting - Liver Cirrhosis Clinical Trials

Extension Study of Carvedilol RCT Study

Start date: January 8, 2021
Phase: N/A
Study type: Interventional

Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients.

NCT ID: NCT04975490 Recruiting - Liver Cirrhosis Clinical Trials

Characterization and Pathogenesis of ACLF

ACLF-I
Start date: December 1, 2020
Phase:
Study type: Observational

This single-center prospective observational study aims at characterization of pathogenesis of ACLF. There will be three different cohorts investigated with the main endpoint mortality in these groups. 1. SAPIENT = Sepsis ACLF patients, to investigate the differences between ACLF and sepsis in cirrhosis 2. PROACT = Portal mediators as ACLF Targets, to assess portal venous biomarkers in patients receiving TIPS leading to ACLF and identify potential treatment targets 3. ELITE = prEdictors of beneficial LIver Tx in ACFL patiEnts, to assess in ACLF-patients receiving liver transplantation predictors of survival, which may improve selection of ACLF-patients for liver transplantation Secondary endpoints will be different in the three different cohorts and biological material will be collected for separate ancillary studies.

NCT ID: NCT04971577 Recruiting - Alcohol Abuse Clinical Trials

Efficacy of Simvastatin in Alcoholic Liver Fibrosis

SIMFIB
Start date: February 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Evaluate the efficacy of simvastatin in reducing liver fibrosis in patients with advanced fibrosis due to alcohol

NCT ID: NCT04956328 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)

Start date: July 22, 2021
Phase: Phase 3
Study type: Interventional

Obecholic acid is a modified bile acid and Farnesoid X receptor (FXR) agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. Conventional therapy with obecholic acid will improve liver function of patients with PBC.