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| ID | Type | Description | Link |
|---|---|---|---|
| 07/0443 | Other Grant/Funding Number | Fondo de Investigación Sanitaria | |
| 07/90077 | Other Grant/Funding Number | Fondo de Investigación Sanitaria |
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| Name | Class |
|---|---|
| Maternal-Infantil Vall d´Hebron Hospital | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
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The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.
End point: To evaluate the effect of long term administration of albumin and midodrine on the prevention of complications associated with cirrhosis in patients with cirrhosis awaiting for liver transplantation.
Secondary end points:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albumin plus midodrine | Active Comparator | Albumin 40 g every 15 days during 1 year or until liver transplantation. Midodrine 5mg/8h. It can be increased according the value of mean arterial pressure. If there is no increase (defined as at least 10mmHGin MAP)midodrine can be increased at a dose of 10mg/8h. This treatment will be given during 1 year or until liver transplantation. |
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| salin solution plus pills | Placebo Comparator | Placebo of albumin in the same schedule thats in arm 1; placebo of midodrine in the same schedule thats in arm 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albumin | Drug | albumine 40 g every 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate complications (renal failure, hepatic encephalopathy, hyponatremia, infection and gastrointestinal bleeding) in patients with cirrhosis awaiting for liver transplant. | When 97 patients are included (% of the whole population) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pere Ginès | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Villarroel 170 | Barcelona | 08870 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19158001 | Background | Alessandria C, Debernardi-Venon W, Carello M, Ceretto S, Rizzetto M, Marzano A. Midodrine in the prevention of hepatorenal syndrome type 2 recurrence: a case-control study. Dig Liver Dis. 2009 Apr;41(4):298-302. doi: 10.1016/j.dld.2008.09.014. Epub 2009 Jan 20. | |
| 18471512 | Background | Martin-Llahi M, Pepin MN, Guevara M, Diaz F, Torre A, Monescillo A, Soriano G, Terra C, Fabrega E, Arroyo V, Rodes J, Gines P; TAHRS Investigators. Terlipressin and albumin vs albumin in patients with cirrhosis and hepatorenal syndrome: a randomized study. Gastroenterology. 2008 May;134(5):1352-9. doi: 10.1053/j.gastro.2008.02.024. Epub 2008 Feb 14. |
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| Midodrine | Drug | Midodrine 5mg/8 hs, can be increase up to 8mg/8hs if there is a lack of increase in at least 10mmHg in mean arterial pressure after 15 days of treatment. |
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| Placebo | Drug | saline solution |
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| 15239086 | Background | Wong F, Pantea L, Sniderman K. Midodrine, octreotide, albumin, and TIPS in selected patients with cirrhosis and type 1 hepatorenal syndrome. Hepatology. 2004 Jul;40(1):55-64. doi: 10.1002/hep.20262. |
| 17389705 | Background | Salerno F, Gerbes A, Gines P, Wong F, Arroyo V. Diagnosis, prevention and treatment of hepatorenal syndrome in cirrhosis. Gut. 2007 Sep;56(9):1310-8. doi: 10.1136/gut.2006.107789. Epub 2007 Mar 27. No abstract available. |
| 15920325 | Background | Guevara M, Gines P. Hepatorenal syndrome. Dig Dis. 2005;23(1):47-55. doi: 10.1159/000084725. |
| 30138685 | Derived | Sola E, Sole C, Simon-Talero M, Martin-Llahi M, Castellote J, Garcia-Martinez R, Moreira R, Torrens M, Marquez F, Fabrellas N, de Prada G, Huelin P, Lopez Benaiges E, Ventura M, Manriquez M, Nazar A, Ariza X, Sune P, Graupera I, Pose E, Colmenero J, Pavesi M, Guevara M, Navasa M, Xiol X, Cordoba J, Vargas V, Gines P. Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial. J Hepatol. 2018 Dec;69(6):1250-1259. doi: 10.1016/j.jhep.2018.08.006. Epub 2018 Aug 21. |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007010 | Hyponatremia |
| D018805 | Sepsis |
| D006501 | Hepatic Encephalopathy |
| D006471 | Gastrointestinal Hemorrhage |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005767 | Gastrointestinal Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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