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Ascites clinical trials

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NCT ID: NCT01777971 Withdrawn - Fatigue Clinical Trials

The Effect of a Large-volume Paracentesis on Fatigue, Sleep, and Quality of Life in Cirrhosis

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

Ascites is the accumulation of fluid within the peritoneal cavity of the abdomen. It is a frequent complication of cirrhosis that is associated with significant morbidity and poor quality of life. Large-volume ascites has been associated with impaired pulmonary function. In a previous study, the presence and severity of ascites were determined to be significant determinants of fatigue. In this study, we will determine whether large-volume ascites contributes to fatigue by assessing the response to drainage of ascites by means of a procedure called large-volume paracentesis. We hypothesize that treatment of ascites with a single large-volume paracentesis leads to decreased fatigue and improved quality of life and that this improvement is associated with improved sleep pattern. 20 patients with cirrhosis with refractory ascites requiring regular drainage of ascites fluid by large-volume paracenteses will be recruited for the study. All patients will undergo a complete clinical and physical examination for liver function, including blood tests. Hepatic encephalopathy, a change in mental status associated with liver dysfunction, will be assessed by obtaining historical data and by means of simple bedside neuropsychological examinations. Study visits will take place on two consecutive days, with each visit lasting approximately 2-3 hours. Immediately prior to a large-volume paracentesis, patients will complete standardized questionnaires for fatigue severity, quality of life, quality of sleep, and a physical assessment of fatigue by means of a 6-minute walk test. Repeat evaluations will be performed 1 day after the procedure. Statistical analysis will then be performed to determine the effect of the paracentesis on the various clinical assessments.

NCT ID: NCT01769040 Completed - Liver Cirrhosis Clinical Trials

Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis

Start date: November 2012
Phase: Phase 4
Study type: Interventional

This investigational trial will be assessing the effect of rifaximin on pathophysiology and haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on several organs on marker level. The molecular and physiological effects of rifaximin will be explored. The investigators hypothesize that intestinal decontamination with rifaximin in patients with cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the following inflammatory response, prevent splanchnic vasodilatation and portal systemic contraction and thereby reduce the risk clinical complications to cirrhosis. If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in liver haemodynamics, renal function and systemic dynamics, then these effects may contribute to the overall well-being of the patient and prevent complications to the underlying cirrhosis such as risk of infections, progression of disease, and admission to hospital.

NCT ID: NCT01716611 Not yet recruiting - Hyponatremia Clinical Trials

Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites

TONIC
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The purpose of the study is to investigate the efficacy and safety for the management of hyponatremia and ascites in patients with liver cirrhosis.

NCT ID: NCT01701297 Terminated - Ascites Clinical Trials

VSL#3 and Spontaneous Bacterial Peritonitis

Start date: February 2012
Phase: Phase 2
Study type: Interventional

Research question: Do oral probiotics in patients with cirrhosis and ascites reduce intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to antibiotics or placebo? This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of "healthy" bacteria for the intestines) compared to an antibiotic or placebo in preventing infection developing in the abdominal fluid ("ascites") that collects in patients with advanced liver disease ("cirrhosis"). Patients already having had infection will be excluded from the study. Clear inclusion and exclusion criteria will be met and patients will be monitored throughout the study to examine whether they have required more hospitalisations, their rate infection in abdominal fluid or elsewhere and the level of liver function.

NCT ID: NCT01578226 Completed - Sepsis Clinical Trials

Procalcitonin in Cirrhotic Patients at High Risk for Sepsis

Start date: October 2009
Phase: N/A
Study type: Observational

Infections are frequent life-threatening events in patients with cirrhosis, occurring at least in 35% of hospitalized patients and accounting for 20% of inpatients death. Among cirrhotics, ascitic patients have the highest risk of death for sepsis. At the admission, no clear-cut clinical and biochemical features are helpful in diagnosing and prognostically stratifying those patients with sepsis. Procalcitonin (PCT)is a breakthrough marker presenting high sensibility and specificity in diagnosing bacterial infections in different clinical settings. The purpose of this study is to evaluate PCT as a diagnostic and prognostic tool for sepsis in hospitalized cirrhotic patients with ascitic decompensation.

NCT ID: NCT01558895 Recruiting - Liver Cirrhosis Clinical Trials

Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites

Start date: March 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity,SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.

NCT ID: NCT01552590 Terminated - Clinical trials for Hyponatremia and Extracellular Fluid in Cirrhotic

Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites

ECF
Start date: April 2012
Phase: Phase 4
Study type: Interventional

This study is to evaluate the efficacy of a 2-week course of tolvaptan in improving serum sodium and the excretion of extracellular fluid in liver cirrhotic patients with ascites and hyponatremia

NCT ID: NCT01532427 Completed - Liver Cirrhosis Clinical Trials

ALFApump System Post Marketing Surveillance Registry

2011-AAR-004
Start date: June 2012
Phase:
Study type: Observational [Patient Registry]

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.

NCT ID: NCT01528410 Completed - Clinical trials for Refractory or Recurrent Ascites

ALFApump System Versus Standard of Care in Ascites Treatment

Start date: August 17, 2012
Phase: Phase 3
Study type: Interventional

This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

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.