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Cirrhosis clinical trials

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NCT ID: NCT02528760 Completed - Cirrhosis Clinical Trials

To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis

Start date: September 24, 2015
Phase: N/A
Study type: Interventional

1. All patients with chronic liver disease admitted in ICU (Intensive Care Unit) to be screened. 2. Patients fulfilling criteria for feed intolerance to be included in the study. 3. Patients to undergo routine biochemical and hematological testing including CBC, KFT, LFT, PT/INR, electrolytes baseline and daily along with ABG (Arterial Blood gas) analysis. 4. Patients with ascites to be tested for presence or absence of SBP (Spontaneous Bacterial Peritonitis). 5. Cultures to be sent as based on clinical parameter of the patient. 6. All correctable causes for intra abdominal hypertension to be corrected including electrolyte imbalance, grade III ascites, intra abdominal infection. 7. Symptoms- Absent bowel sounds (BS)= no BS detected by auscultation. Vomiting/regurgitation= any visible regurgitation of gastric contents; Diarrhoea= liquid stool > or =3 times/day; Bowel distension= suspected clinically and radiologically confirmed; Large gastric residual volume (GRV) of >or =500 ml/24 h on a single day or > 200ml at any time of the day. 8. Per abdomen findings to be checked daily including presence of bowel sounds, tenderness, development of abdominal distension, abdominal girth monitoring and abdominal pressure monitoring. 9. Patients who develop feed intolerance will be included. 10. Feed intolerance to be defined as per study definition (3 out of 5 symptoms). 11. Measurement of GRV (Gastric residual volume) to be done at 4 hourly interval. 12. Methods for measuring GRV by either gravity drainage by connecting a gastric tube to a drainage bag for 10min or by manual aspiration of content using a 50ml syringe. 13. Once feed intolerance develop than every 6 hourly intra abdominal pressure monitoring and abdominal girth monitoring to be done (24) 14. Intra bladder pressure to be measured using Foleys manometer technique (25). 15. Pressure measured in cm of water to be converted into mm of Hg. 16. X ray abdomen supine to look for bowel distension, defined as more than 3 cm for small bowel and more than 5 cm in large bowel. 17. Development of intra abdominal hypertension based on intra abdominal pressure. 18. Patient to be stratified according to the grade of intra-abdominal hypertension. 19. After correction of all correctable causes, if feed intolerance persists, then patient to be randomized by block randomization method into 3 arms, metaclopromide group, erythromycin group or placebo group. 20. Daily assessment of bowel sounds, abdominal pressure, abdominal girth every 6 hourly and gastric residual volume to be noted every 4 hourly. 21. Response of therapy to be assessed at 24 hours in each arm. 22. Response to be assessed by resolution of feed intolerance or initiation of entral nutrition. 23. Metoclopromide to be given 10mg iv 8 hourly. 24. Erythromycin to be given 70mg iv 12 hourly (26). 25. Placebo arm to receive normal saline in 10ml syring twice daily. 26. After 24 hours of treatment if symptoms do not resolve than rescue treatment will be given to each arm which may include continuation of prokinetics, add on prokinetic, flatus tube insertion for bowel decompression, upgradation of antibiotics or search for any other cause, as per the patient response. 27. Therapy to continue for a total duration of 72 hours. 28. If there is no response at 72 hours, than study stops. 29. If patient responds to given treatment, study to continue for a total duration of 7 days. 30. Assessment to continue in each arm for a maximum period of 7 days.

NCT ID: NCT02508298 Completed - Cirrhosis Clinical Trials

Surrogate Markers of Portal Pressure

Start date: April 2014
Phase: N/A
Study type: Interventional

This is a prospective longitudinal study that will evaluate if changes (pre and post therapy) in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS) as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.

NCT ID: NCT02484963 Completed - Cirrhosis Clinical Trials

The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

Start date: May 15, 2015
Phase: N/A
Study type: Interventional

All Cirrhosis liver patients (Child A/B/C) presenting to Institute of Liver and Biliary Sciences will be screened for sleep disturbance and excessive daytime sleepiness with Epworth sleep score/ Pittsburgh sleep quality index. 52 patients of clinical/ radiological/ biopsy proven cirrhosis (Child A/B) will be enrolled after ruling out possibility of psychiatric illnesses like depression and anxiety with the help of PHQ-9 / GAD-7 questionnares. Patients who are suffering with sleep disturbance as evaluated with Pittsburgh sleep quality index will undergo polysomnography and will be randomised to two groups after fulfilling all inclusion criterias. Patients in group (Group 1) will receive zolpidem 5mg at bed time daily and patients in control group will receive placebo at bed time daily. The treatment will be continued for 4 weeks. After 4 weeks enrolled patients will be reassessed with PSQI and polysomnography. All patients will be advised regarding sleep hygiene.

NCT ID: NCT02484534 Completed - Cirrhosis Clinical Trials

Thrombin Generation Test in Patient With Liver Cirrhosis

Start date: February 26, 2015
Phase: N/A
Study type: Observational

Cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. The importance increases when these patients waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable measure of mortality risk in patients with end-stage liver disease. It is used as a disease severity index to help prioritize allocation of organs for transplant. MELD uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of Anticoagulant of the equation and not the side of the procoagulant . To examine the coagulation system function tests have been developed, One of them is the thrombin generation. The purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.

NCT ID: NCT02480972 Completed - Cirrhosis Clinical Trials

Hepatic Fibrosis Assessment Using Multiparametric Magnetic Resonance Imaging

Start date: June 23, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to assess degree of hepatic fibrosis using multiparametric MRI for investigating difference between normal or early fibrosis and advanced fibrosis.

NCT ID: NCT02475122 Completed - Cirrhosis Clinical Trials

Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)

AzyMR
Start date: October 2014
Phase: N/A
Study type: Interventional

Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005). The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years. In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012). So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009). Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement. However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.

NCT ID: NCT02457403 Completed - Cirrhosis Clinical Trials

Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy

SCARLET
Start date: May 2015
Phase: N/A
Study type: Interventional

A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).

NCT ID: NCT02451033 Completed - Cirrhosis Clinical Trials

Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver: An Open Label Study

Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC) have poor prognosis and further decreases the survival in these patients. It has been believed that cirrhosis is irreversible and that treatment should focus on preventing the progression of liver fibrosis/dysfunction and its complications. Currently the only effective treatment is liver transplantation, an increasingly limited and expensive resource especially in developing countries. Furthermore, transplantation comes with a requirement for lifelong immunosuppression, and considerable long-term side effects that include chronic renal failure, post-transplant lymphoproliferative disease, and cardiovascular complications. Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for patients with end stage liver diseases. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells. Animal and human studies suggested that such cells might contribute to the regeneration after different kinds of liver injuries . In animal models, after liver injury, bone marrow-derived circulating pluripotent cells have been reported to participate in liver repopulation with both non-parenchymal cells and hepatocytes. This repopulation process, however, seems to be highly dependent on the type of liver injury and experimental conditions. Fusion with hematopoietic cells has been substantiated as a mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver histology and survival in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient data on whether G-CSF improves survival and prognosis in patients with cirrhosis. Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis . However there is scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis.

NCT ID: NCT02442284 Completed - Cirrhosis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

Start date: May 13, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

NCT ID: NCT02439567 Completed - Cirrhosis Clinical Trials

Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)

SPLEEN-C
Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.