Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial
| Autor: | Gloria de Prada, Núria Fabrellas, Pere Ginès, Miquel Navasa, Eva Lopez Benaiges, Pilar Suñé, Meritxell Ventura, Marta Martín-Llahí, Francisca Márquez, Mónica Guevara, Isabel Graupera, Rebeca Moreira, Macarena Simón-Talero, Marcela Manríquez, J. Cordoba, Xavier Xiol, José Castellote, Victor Vargas, A. Nazar, Elsa Solà, Elisa Pose, Jordi Colmenero, Marco Pavesi, Xavier Ariza, M. Torrens, Rita Garcia-Martínez, P. Huelin, Cristina Solé |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Liver Cirrhosis Male medicine.medical_specialty Gastrointestinal bleeding Cirrhosis medicine.medical_treatment Midodrine Placebo-controlled study Kaplan-Meier Estimate Liver transplantation Gastroenterology 03 medical and health sciences Norepinephrine 0302 clinical medicine Double-Blind Method Internal medicine Albumins Ascites Renin medicine Humans Vasoconstrictor Agents Renal Insufficiency Hepatic encephalopathy Aldosterone Aged Hepatology business.industry Shock Transplant Waiting List Middle Aged medicine.disease Liver Transplantation Treatment Outcome 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Female medicine.symptom business medicine.drug Follow-Up Studies Hyponatremia |
| Zdroj: | Journal of hepatology. 69(6) |
| ISSN: | 1600-0641 |
| Popis: | Patients with decompensated cirrhosis on the waiting list for liver transplantation (LT) commonly develop complications that may preclude them from reaching LT. Circulatory dysfunction leading to effective arterial hypovolemia and activation of vasoconstrictor systems is a key factor in the pathophysiology of complications of cirrhosis. The aim of this study was to investigate whether treatment with midodrine, an alpha-adrenergic vasoconstrictor, together with intravenous albumin improves circulatory dysfunction and prevents complications of cirrhosis in patients awaiting LT.A multicenter, randomized, double-blind, placebo-controlled trial (NCT00839358) was conducted, including 196 consecutive patients with cirrhosis and ascites awaiting LT. Patients were randomly assigned to receive midodrine (15-30 mg/day) and albumin (40 g/15 days) or matching placebos for one year, until LT or drop-off from inclusion on the waiting list. The primary endpoint was incidence of any complication (renal failure, hyponatremia, infections, hepatic encephalopathy or gastrointestinal bleeding). Secondary endpoints were mortality, activity of endogenous vasoconstrictor systems and plasma cytokine levels.There were no significant differences between both groups in the probability of developing complications of cirrhosis during follow-up (p = 0.402) or one-year mortality (p = 0.527). Treatment with midodrine and albumin was associated with a slight but significant decrease in plasma renin activity and aldosterone compared to placebo (renin -4.3 vs. 0.1 ng/ml.h, p 0.001; aldosterone -38 vs. 6 ng/dl, p = 0.02, at week 48 vs. baseline). Plasma norepinephrine only decreased slightly at week 4. Neither arterial pressure nor plasma cytokine levels changed significantly.In patients with cirrhosis awaiting LT, treatment with midodrine and albumin, at the doses used in this study, slightly suppressed the activity of vasoconstrictor systems, but did not prevent complications of cirrhosis or improve survival.Patients with cirrhosis who are on the liver transplant waiting list often develop complications which prevent them from receiving a transplant. Circulatory dysfunction is a key factor behind a number of complications. This study was aimed at investigating whether treating patients with midodrine (a vasoconstrictor) and albumin would improve circulatory dysfunction and prevent complications. This combined treatment, at least at the doses administered in this study, did not prevent the complications of cirrhosis or improve the survival of these patients. |
| Databáze: | OpenAIRE |
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