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Ascites clinical trials

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NCT ID: NCT06266091 Active, not recruiting - Malignant Ascites Clinical Trials

Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody

Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

A Phase II, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of M701 in treating Patients with Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer combined with Systemic Therapy.

NCT ID: NCT06256432 Recruiting - Acute Kidney Injury Clinical Trials

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Start date: March 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: NCT06245590 Not yet recruiting - Clinical trials for Decompensated Cirrhosis

Evaluation of Low-dose Albumin and Midodrine Versus Midodrine Alone in Outcome of Recurrent Ascites in Patients With Decompensated Cirrhosis.

Start date: February 10, 2024
Phase: N/A
Study type: Interventional

The project is about evaluation of albumin and midodrine versus midodrine alone in outcome of recurrent ascites in patients with decompensated cirrhosis. Cirrhosis occcurs in 50% of patients over 10 years. The mortality is approximately 40% at 1 year and 50% at 2 years (12.7 per 100,000 population). A lot of times the prognosis is poor and the main factors leading to it are - acute kidney injury, hepatorenal syndrome, hyponatremia, grade of ascites-recurrent ascites, sarcopenia, low mean arterial pressure. Post review of the literature, it is realized that there are some gap areas - - It is unknown whether combination of vasoconstrictor with albumin versus vasoconstrictor alone is superior for ascites resolution in patients with recurrent ascites. - There are no studies till date on using combination of vasoconstrictor with albumin versus vasoconstrictor alone in patients with recurrent ascites. - There are no studies on impact of combining vasoconstrictor and albumin in preventing the development of AKI and chronic kidney disease in these patients. In an effort to bridge these gap areas, this project works on the following hypothesis - "Midodrine would have a synergistic effect with albumin in improving the systemic hemodynamics and circulatory dysfunction and will cause rapid control of ascites, reduce the incidence of large volume paracentesis (LVP), complications, reduce the incidence of chronic kidney disease (HRS-CKD) and improve outcome of patients with recurrent ascites in patients with decompensated cirrhosis as compared to midodrine alone" Primary objective: To assess the effect of midodrine alone vs. a combination of midodrine and albumin on the survival free of TIPS and liver transplant at 6 months Secondary objective: The effect of midodrine alone vs. combination of midodrine and albumin on the cumulative frequency of therapeutic paracentesis at 6 and 12 months Proportion of patients achieving control of ascites at 6 and 12 months

NCT ID: NCT06224023 Not yet recruiting - Cirrhosis, Liver Clinical Trials

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

PASS
Start date: January 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: NCT06200376 Recruiting - Malignant Ascites Clinical Trials

A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

Start date: September 28, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

NCT ID: NCT06196723 Completed - Refractory Ascites Clinical Trials

Early Transjugular Intrahepatic Portosystemic Shunts Improve Survival in Patients With Cirrhosis and Recurrent Ascites

TIPS
Start date: December 1, 2023
Phase:
Study type: Observational

Currently, there is limited evidence regarding the survival benefit of early transjugular intrahepatic portal shunt (TIPS) placement in patients with cirrhosis and recurrent ascites. This observational study aimed to assess whether early TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites. We will compare large volume paracenteses plus albumin (LVP+A) to see if TIPS improves the survival of patients with advanced cirrhosis and recurrent ascites.

NCT ID: NCT06121479 Recruiting - Clinical trials for Decompensated Cirrhosis and Ascites

Oral Branched-chain Amino Acid Supplementation for Decompensated Cirrhotic Patients

Start date: November 13, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the nutritional parameters after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL. The main questions it aims to answer are: 1. Would thigh muscle thickness change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 2. Would triceps skin fold thickness, mid-arm circumferences, mid-arm muscle circumferences, skeletal muscle mass, appendicular skeletal muscle mass, skeletal muscle index and fat mass change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 3. Would handgrip strength change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 4. Would serum albumin change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? 5. Would score for cirrhotic severity such as Model for End-Stage Liver Disease-Sodium Score (MELD-Na score) and Child Turcotte Pugh Score change after 12-week supplementation of branched-chain amino acids in cirrhotic patients with ascites and serum albumin less than 3 g/dL? Participants will be asked to do following tasks: 1. Participants will be asked for basic information such as age, place of residence, and contact telephone number. 2. Participants will undergo measurements of weight, height, body mass index, skinfold thickness on the arms, circumference of the arms and legs, muscle mass, and body fat content using a body composition analyzer, both at the beginning and end of the research study. 3. Participants will perform grip strength measurements, at both the beginning and end of the research study. 4. Participants will undergo laboratory tests, including a complete blood count, liver and kidney function tests, blood clotting factors, and blood mineral levels, with a total blood volume of approximately 15 milliliters (1 tablespoon), collected twice during the study (at the beginning and end). 5. Participants will be administered supplements containing branched-chain amino acids (BCAA) twice a day for a total of 12 weeks. 6. Participants will be appointed for follow-up during the study, totaling 2 appointments at weeks 4 and 12. Side effects related to medication will be asked. 7. Participants will undergo ultrasound measurements of the right thigh to assess thigh muscle thickness, both at the beginning and end of the research study. 8. Participants will will complete questionnaires to assess your overall quality of life twice, both at the beginning and end of the research study.

NCT ID: NCT06091345 Not yet recruiting - Liver Cirrhosis Clinical Trials

Midodrine Plus Albumin Versus Midodrine Alone to Prevent Cirrhosis Related Complications in Children With Cirrhosis and Ascites

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

Children with decompensated cirrhosis are more prone to develop various complications. The pathogenesis of cirrhotic complications (ascites, hyponatremia, acute kidney injury) includes release of vasodilatory molecules like nitric oxide, damage associated molecular pathogens (DAMPs) and pattern associated molecular pathogens (PAMPs) secondary to bacterial translocation, which causes splanchnic bed vasodilation resulting in activation of renin-angiotensin and aldosterone axis (RAAS) causing sodium and water retention and renal vasoconstriction. The development of complications in these children may result in death or may preclude them from reaching upto liver transplantation. Midodrine is an α1 adrenergic receptor agonist, which increases vascular tone causing rise in the blood pressure, thereby improving renal perfusion and causes RAAS deactivation. The effects of midodrine is documented in reduction of refractory ascites, hepatorenal syndrome and hyponatremia. Albumin is a protien that works by both increasing the colloidal oncotic pressure and improving systemic circulation as well as by effecting the body with anti-inflammatory and antioxidant properties. We have already demonstrated the safety and efficacy of midodrine as well as albumin in cirrhotic children. However, none of these drugs alone provided survival benefit to the patients. Hence, we have planned this study with the ojective to evaluate if combining these 2 drugs (midodrine and albumin) would further reduce the complications and improve the survival in decompensated cirrhotic children.

NCT ID: NCT06046963 Recruiting - Gastric Cancer Clinical Trials

Sintilimab in Combination With S-1/Oxaliplatin With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of Sintilimab in Combination With S-1/oxaliplatin With nab-paclitaxel intraperitoneal infusion as First-line Treatment for advanced gastric/gastroesophageal junction (GC/GEJ) adenocarcinoma with malignant ascites

NCT ID: NCT06016179 Recruiting - Clinical trials for Malignant Pleural Effusion

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer

RIOT2
Start date: January 30, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.