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Cirrhosis clinical trials

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NCT ID: NCT03145168 Completed - Cirrhosis Clinical Trials

High Versus Low Target Mean Arterial Pressure in Septic Shock in Critically Ill Cirrhotics

Start date: September 19, 2018
Phase: N/A
Study type: Interventional

Study Design: - A randomized controlled study. - The study will be conducted on patients admitted to Department of Hepatology from April 2017 to October 2017 at ILBS, New Delhi - Study group will comprise of patients critically ill cirrhotics with septic shock All included patients would be randomised to low target MAP group (60-65mm Hg) or high target group (80-85 mm of Hg). Patients older than 18 years of age will be enrolled if they have septic shock that is refractory to fluid resuscitation and if they required vasopressors (norepinephrine or epinephrine or terlipressin) at a minimum infusion rate of 0.1 μg per kilogram per minute. Standard criteria will be considered to define refractoriness to fluids. The target MAP would be maintained for a max. of 5 days or until recovery or shock and or AKI. In the high-target group, a reduction in vasopressor doses to maintain a mean arterial pressure of 65 to 70 mm Hg will be done in case of any of the prespecified serious adverse events that could potentially be related to an increased rate of vasopressor infusion occurred. These events could be: clinically relevant bleeding (i.e., transfusion requirements of at least 2 units of packed red cells), myocardial infarction (defined as typical electrocardiographic changes, with a concomitant increase in troponin, and segmental echocardiographic hypokinesia or akinesia, with the infarction confirmed, when possible, by means of coronary angiography), major ventricular arrhythmia, poorly tolerated supraventricular arrhythmia, mesenteric ischemia, and distal-limb ischemia. • Septic shock would be defined as clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP>=65 mm of Hg and having a serum lactate >2 mmol/L despite adequate volume resuscitation

NCT ID: NCT03144713 Completed - Cirrhosis Clinical Trials

Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

Start date: May 28, 2017
Phase: N/A
Study type: Interventional

- Study Population: Patients admitted or seen in Out Patient Department, Department of Hepatology, Institute of Liver and Biliary Sciences. - Study Design: Prospective Open Labeled Randomized Controlled Trial. - Study Period: January 2017 to December 2017 - Intervention- Subjects will be randomized to 3 groups - All patients will receive Standard medical therapy - Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping. Group A - Subjects will receive Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg) Group B - Midodrine 7.5 mg TDS x 3 days Group C - Standard medical therapy only - Monitoring and Assessment: Clinical evaluation will be done at regular intervals. - Adverse Effects: Rise in blood pressure, arrthymias, hyponatremia and rarely cardiovascular side effects have been noted. - Stopping Rule: Development of PICD, hypertension ( BP>160/90mmhg-JNC class II)

NCT ID: NCT03137719 Completed - Cirrhosis Clinical Trials

Infections in Hospitalized Cirrhotic Patients

Start date: January 1, 2011
Phase:
Study type: Observational

Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas: 1. Community-acquired infections 2. Nosocomial infections 3. Development of second infections 4. Factors predicting ICU care, organ failure, death, and disability 5. Patterns and adequacy of albumin use in infected and non-infected patients 6. Per and post-liver transplant outcomes 7. Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia 8. Regional variations in outcomes and therapeutic strategies

NCT ID: NCT03123666 Active, not recruiting - Cirrhosis Clinical Trials

Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

Start date: April 19, 2017
Phase: N/A
Study type: Interventional

Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.

NCT ID: NCT03121404 Recruiting - Cirrhosis Clinical Trials

Mechanisms of Malnutrition in Cirrhosis With Portosystemic Shunting

Start date: November 14, 2008
Phase:
Study type: Observational

Cirrhosis is characterized by loss of muscle as well as fat mass, which increases morbidity and mortality before, during, and after liver transplantation. A common mechanism for the reduced muscle and fat mass in cirrhosis is an increased expression of the TGF (transforming growth factor)beta superfamily member, myostatin, in the muscle and adipose tissue. The present study will examine the expression of myostatin, its receptor and intracellular signaling pathways in the skeletal muscle and mesenteric adipose tissue in cirrhotic patients undergoing liver transplantation as compared to healthy controls undergoing planned abdominal surgery. 16 cirrhotic patients will be identified from the transplant list, and 16 healthy controls from outpatient surgery lists. Nutritional assessment will be performed, including anthropometry (triceps skinfold thickness, mid arm circumference), dual energy x-ray absorptiometry (DEXA), and bioelectrical impedance analysis (BIA). Rectus abdominis muscle tissue and omental fat tissue will be harvested in the operating room, and the expression of signaling proteins involved in skeletal muscle protein synthesis will be quantified. The investigator will also quantify the expression of genes involved in lipolysis and lipid synthesis. The investigator anticipates that the expression of myostatin will be higher in the skeletal muscle and adipose tissue of cirrhotics as compared to controls. There will be a reduction in the expression of the signaling proteins that regulate skeletal muscle protein synthesis, as well as the expression of genes regulating lipogenesis. The increased expression of myostatin will also correlate with reduced anthropometric and DEXA measurements of lean body mass and fat mass.

NCT ID: NCT03107091 Completed - Cirrhosis Clinical Trials

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Start date: July 15, 2017
Phase: Phase 2
Study type: Interventional

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.

NCT ID: NCT03091738 Completed - Cirrhosis Clinical Trials

Ramelteon for Treatment of Insomnia in Cirrhosis

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

To study the effect of ramelteon, a melatonin receptor agonist, on sleep quality, duration and cognitive function in cirrhotics with insomnia. Patients with cirrhosis have difficulties with their sleep quality, which adversely affects their health-related quality of life. It is assumed the sleep disturbances are related to hepatic encephalopathy (HE) in these patients. However, several recent reports have indicated that this is not a perfect concordance and that cognition is not related to sleep disturbance. The mechanism for this change is not clear, although there is evidence of melatonin-delayed phase in these patients as well as difficulties with the excretion pattern of cortisol. Ghrelin is an orexigenic hormone produced by the stomach which stimulates the appetite and also has a profound effect on sleep. Our group has demonstrated a substantial alteration in ghrelin secretion in cirrhosis that correlates with poor slow-wave sleep. In healthy individuals, ghrelin injection encourages slow-wave sleep while sleep deprivation increases ghrelin levels. The role of ghrelin in the sleep disturbances of cirrhosis has not been determined. Prior studies have also lacked the use of overnight polysomnography as a tool and have relied on either actigraphy or questionnaires. There is a need for detailed mechanistic and therapeutic approaches to analyzing sleep disturbances in cirrhosis. Also the therapy of sleep disturbance in cirrhosis is largely empirical. Prior studies have evaluated hydroxyzine which runs the risk of precipitating HE. Ramelteon is a melatonin analog that is FDA-approved for use in insomnia and will potentially be useful to restore the sleep-wake cycle in cirrhosis-associated sleep disturbance. The investigators aim to study the impact of the FDA-approved ramelteon on the sleep quality (using questionnaires and sleep diaries) on these patients with cirrhosis.

NCT ID: NCT03085342 Active, not recruiting - Cirrhosis Clinical Trials

Evaluation of Hepatic Fibrosis on Multiparametric MRI

Start date: April 4, 2017
Phase: N/A
Study type: Interventional

As cirrhosis progresses, alteration of hemodynamics develops and decreased portal flow is often observed. Since direct measurement of portal pressure (HVPG) is invasive, non-invasive methods have drawn a lot of attention. MRI is one of the non-invasive methods and it is able to provide multiparametric data in one examination. Herein, we evaluate hepatic fibrosis with different stage using multiparametric MRI with emphasis on portal flow measurement.

NCT ID: NCT03084185 Recruiting - Cirrhosis Clinical Trials

Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

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

This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients. The duration of the study is 36 months and it provides a cohort of 200 patients.

NCT ID: NCT03071458 Completed - Clinical trials for HepatoCellular Carcinoma

Mutational Landscape in Hepatocellular Carcinoma

MUTHEC
Start date: January 2008
Phase: N/A
Study type: Observational

The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC treated by curative treatments (resection, radio frequency ablation, transplantation) as well as advanced HCC together with the analysis of circulating tumor DNA.