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Ascites clinical trials

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NCT ID: NCT02530398 Recruiting - Malignant Ascites Clinical Trials

A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites

Start date: July 2015
Phase: Phase 1
Study type: Interventional

To evaluate the tolerance and safety of cinobufacini injection intraperitoneal treatment on digestive system cancer patients with malignant ascites, and propose dosage regimens for future clinical trials. The clinical trial is divided into two parts, including single and successive administration.

NCT ID: NCT02501213 Terminated - Cancer Clinical Trials

Evaluation of the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Stage of Cancer (DIASC)

Start date: May 30, 2016
Phase: Phase 2
Study type: Interventional

While some authors recommend diuretics as the first treatment to initiate for symptoms caused by malignant ascites (MA), their prescription is variable. No randomized, controlled study has assessed their benefit in this context. According to literature, diuretics may bring relief in about 40% of cases, regardless of primary tumor. The purpose of our study is to assess the effectiveness of diuretic treatment according to Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the time elapsed between recurrent MA that requires paracentesis. The investigators will also examine whether SAAG and serum levels of renin and aldosterone can predict symptom response to diuretics.

NCT ID: NCT02496286 Terminated - Malignant Ascites Clinical Trials

Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Start date: June 2015
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

NCT ID: NCT02477657 Withdrawn - Clinical trials for Refractory Malignant Ascites

Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology

Start date: July 2021
Phase:
Study type: Observational

Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.

NCT ID: NCT02465619 Withdrawn - Cirrhosis Clinical Trials

To Study and Compare the Clinical Course and Development of Organ Failure in Severe Acute Hepatitis Without Ascites, Non-cirrhotic and Cirrhotic Patients With Ascites [Acute on Chronic Liver Failure] and Acute Deterioration of Previously Decompensated Cirrhosis.

Start date: n/a
Phase: N/A
Study type: Observational

The study will be conducted on patients admitted to Department of Hepatology from MARCH 2015 to DECEMBER 2016 at ILBS, New Delhi.All patients presenting to ILBS fulfilling the inclusion criteria will be included in the study and will be categorized and evaluated. The patient will followed over a period of 3 months.

NCT ID: NCT02421848 Completed - Liver Cirrhosis Clinical Trials

Lean Mass Evaluation of Cirrhotic Patients With Ascites With the Use DXA

BCECPA
Start date: January 2012
Phase: N/A
Study type: Observational

Malnutrition due to liver disease is common, however, their detection is difficult. The parameters used for nutritional assessment in clinical practice have limited use in this patient population. From this perspective, this study proposes to develop predictive equations for body composition for electrical bioimpedance (BIA) in cirrhotic patients. Besides being a fast and risk free, the BIA offers the additional advantage of low cost compared to other methods that assess body composition (BC). Will be selected patients male with liver cirrhosis (n = 112) of the Liver Transplant Clinic of the Hospital of the Clinicas, Faculty of Medicine, University of São Paulo. This pioneering study is of great clinical importance because malnutrition is a relevant factor in the prognosis of liver disease and there is not efficient method in clinical practice to properly assess the body composition in this population.

NCT ID: NCT02417753 Terminated - Ovarian Cancer Clinical Trials

AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites

Start date: April 3, 2015
Phase: Phase 2
Study type: Interventional

Background: - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer. Objective: - To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer. Eligibility: - Adults age 18 and older with a malignancy of the GI tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen. Design: - Participants will be screened with: - Medical history, physical exam, and blood tests. - Echocardiogram: sound waves make images of the heart. - Electrocardiogram: measures electrical activity of the heart. - Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid. - They may have a tumor biopsy. - Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days. - Each cycle, participants will: - Have a physical exam. - Have blood tests weekly. - Be asked about how they feel and any medicines they are taking. - After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor. - Participants will have paracentesis 2 more times during the study. They will have another echocardiogram. - At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.

NCT ID: NCT02400164 Completed - Cirrhosis Clinical Trials

A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites

MOSAIC
Start date: March 2015
Phase: N/A
Study type: Interventional

The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.

NCT ID: NCT02173288 Completed - Cirrhosis Clinical Trials

Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites

Start date: July 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The development of ascites in the natural history of cirrhosis heralds a worsening of the prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to neurohumoral systems are essential in pathophysiology of ascites formation. The theory that best explain the ascites formation and sodium retention in cirrhotics is portal hypertension leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine vasopressin), resulting in sodium and water retention. The therapeutic options available for patients with refractory ascites are serial therapeutic paracentesis, liver transplantation and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal collecting duct, they increase free water clearance, and thus may be helpful in mobilizing excess water in conditions associated with water retention including cirrhosis. The use of V2 receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious. Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor antagonists) by acting at different sites in combination may reverse some of the pathogenic events that results in refractory or recurrent ascites.There are no reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis with ascites. Therefore, we plan to study the role of midodrine, tolvaptan and their combination on systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and refractory or recurrent ascites.

NCT ID: NCT02163512 Completed - Hepatic Cirrhosis Clinical Trials

Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites

ALB-BET
Start date: March 12, 2014
Phase:
Study type: Observational

Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.