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Cirrhosis clinical trials

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NCT ID: NCT02026609 Terminated - Cirrhosis Clinical Trials

Glutamine Challenge as Predictor of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Start date: May 2013
Phase: N/A
Study type: Observational

Transjugular intrahepatic portosystemic shunt (TIPS) is the first-line therapy for patients with cirrhosis and refractory ascites. However, mental changes known as hepatic encephalopathy (HE) frequently occur after TIPS. There is no effective method to predict HE after TIPS. Oral glutamine challenge (OGC) and psychometric tests have been used to assess the risk for HE, but never in patients undergoing TIPS. Severe muscle loss may also predispose patients to HE. The aim of the present study is to assess if both the OGC and psychometric tests can accurately predict the development of overt HE after TIPS. Patients will be studied before TIPS and followed after TIPS for the development of HE. The role of muscle loss in favoring HE, as well as is possible reversibility after TIPS will also be investigated.

NCT ID: NCT01954524 Terminated - Cirrhosis Clinical Trials

A Phase 1, Open-Label Study of Intravenous Sildenafil in Patients With Cirrhosis

Start date: May 2014
Phase: Phase 1
Study type: Interventional

Safety and tolerability of a single dose intravenous bolus injection of Sildenafil in patients with moderate to severe cirrhosis and kidney disease will be determined.

NCT ID: NCT01846819 Terminated - Depression Clinical Trials

Factors Associated With End Stage Liver Disease

Start date: July 2012
Phase: N/A
Study type: Observational

100 ambulatory cirrhotic patients attending a liver transplant clinic will undergo a comprehensive clinical evaluation for severity of liver disease, anemia, depression, and fatigue. Fatigue will be assessed with the FIS and sub-maximal exercise capacity with the 6-minute walk test (6MWT), a standardized exercise test that measures the distance that a patient is capable of walking in 6 minutes (6MWD). Depression will be assessed by using three well-known questionnaires. The SF-36, Beck's Depression Inventory (BDI-II), EQ-5D, and the Psychological General Well-Being Index (PGWBI). Univariate analysis will be performed to select the factors that potentially are associated with the scores as indicated by a P value <.20; the selected factors will then be entered in a stepwise regression to create a multivariate model giving the combination of factors that are significantly associated with the measure of fatigue and depression. Hemoglobin (Hb) levels will then be added to the model in order to test its significance while controlling for the other factors.

NCT ID: NCT01455246 Terminated - Cirrhosis Clinical Trials

Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis

Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Nosocomial spontaneous bacterial peritonitis (SBP) is frequently caused by multi drug resistant bacteria. Standard treatment of SBP could be ineffective. The aim of the study is to compare daptomycin + meropenem vs ceftazidime in the treatment of nosocomial SBP.

NCT ID: NCT01359813 Terminated - Sepsis Clinical Trials

Albumin Administration in Cirrhotic Patients With Bacterial Infection and a Systemic Inflammatory Response Syndrome Unrelated to Spontaneous Bacterial Peritonitis

ALB-CIRINF
Start date: December 2008
Phase: Phase 3
Study type: Interventional

Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites. The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score > 8.

NCT ID: NCT01037959 Terminated - Cirrhosis Clinical Trials

Norfloxacin Therapy for Patients With Cirrhosis and Severe Liver Failure

NORFLOCIR
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that this translocation may worsen the underlying liver disease. Thus, the aim of this trial was to assess the effects of the oral administration of norfloxacin (an antibiotic that suppresses intestinal Gram-negative bacteria) on the development of complications of cirrhosis.

NCT ID: NCT00742339 Terminated - Cirrhosis Clinical Trials

Terlipressin + Albumin Versus Midodrine + Octreotide in the Treatment of Hepatorenal Syndrome

Start date: May 2005
Phase: Phase 2/Phase 3
Study type: Interventional

From 1999, several studies have showed that the use of vasoconstrictors in association with albumin are effective in the treatment of hepatorenal syndrome (HRS). The rationale of the use of vasoconstrictors together with albumin in the treatment of this severe complication of portal hypertension in patients with cirrhosis is to correct the reduction of the effective circulating volume due to the splanchnic arterial vasodilatation.In most of these studies terlipressin, a derivate of vasopressin, has been used as vasoconstrictor as intravenous boluses moving from an initial dose of 0.5-1 mg/4 hr. In some studies midodrine, an alpha-adrenergic agonist, given by mouth has been used as vasoconstrictor at a dose ranging from 2.5 up to 12.5 tid together with octreotide, an inhibitor of the release of glucagon, given subcutaneously at a dose ranging from 10 µg upt to 200 µg tid. To the day, there isn't a study comparing terlipressin + albumin versus midodrine + octreotide + albumin in the treatment of HRS in patients with cirrhosis.Thus, the aim of the study is to compare terlipressin + albumin vs midodrine + octreotide + albumin in the treatment of the HRS in patients with cirrhosis.

NCT ID: NCT00485290 Terminated - Cirrhosis Clinical Trials

Effect of Meal on Portal and Esophagus Variceal Pressure

VIPE
Start date: June 2007
Phase: N/A
Study type: Interventional

The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a meal on variceal pressure with a non invasive endoscopic measurement device, and compare it with portal pressure.

NCT ID: NCT00401895 Terminated - Cirrhosis Clinical Trials

Transjugular Intrahepatic Portosystemic Shunt With 8- or 10-mm Covered Stents

Start date: January 2006
Phase: Phase 2
Study type: Interventional

Coated stents with different diameters are presently commercially available, but clinical studies on the assessment of the best stent diameter for a better clinical efficacy, a reduced number of complications, and an effective portal pressure reduction (essential in the treatment of those pathologies in which TIPS is indicated) still do not exist. Aim of the study The purpose of our study is to compare the clinical efficacy and the incidence of complications of TIPS created with 8- and 10-mm covered stents in patients with hepatic cirrhosis.

NCT ID: NCT00375011 Terminated - Cirrhosis Clinical Trials

Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics

Start date: September 2008
Phase:
Study type: Observational

The three objectives of this trial are: 1. To demonstrate that a decline in hepatic metabolic function as measured by BreathID will correlate with changes in CTP and MELD scores in patients with cirrhosis. 2. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk to develop complications of cirrhosis. 3. To determine the critical value of hepatic metabolic function as measured by BreathID will predict which patients are at risk for liver related mortality. The hypothesis is that the BreathID breath test will correlate to CTP and MELD scores, and that thresholds can be established that will help predict risk of complications of cirrhosis and mortality.