Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial

Solà, Elsa; Solé, Cristina; Simón-Talero, Macarena; Martín‐Llahí, Marta; Castellote, José; García-Martinez, Rita; Moreira, Rebeca; Torrens, M.; Márquez, Francisca Benavides; Fabrellas, Núria; Prada, Glòria de; Huelín, Patrícia; Benaiges, Eva Lopez; Ventura, Meritxell; Manríquez, Marcela; Nazar, A.; Ariza, Xavier; Suñé, Pilar; Graupera, Isabel; Pose, Elisa; Colmenero, Jordi; Pavesi, Marco; Guevara, Mónica; Navasa, Miquel; Xiol, Xavier; Córdoba, Joan; Vargas, Vı́ctor; Ginès, Pere

doi:10.1016/j.jhep.2018.08.006

Cited by 169 publications

(232 citation statements)

References 40 publications

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“…Contrasting results emerged from the MACHT study, a multicenter, double-blind, randomized trial that enrolled patients with decompensated cirrhosis on the waiting list for LT. (27) The full analysis set Despite a small but significant decrease in plasma renin activity and aldosterone, suggesting a favorable effect on systemic hemodynamics, both the probability of developing complications of cirrhosis during the follow-up, even though the episodes of hyponatremia and renal failure were more severe in patients enrolled in the placebo group, and 1-year mortality did not differ between the 2 arms of the study. No effects of albumin administration on the circulating levels of proinflammatory cytokines were seen.…”

Section: Available Evidence On the Effects Of Longterm Albumin Adminimentioning

confidence: 98%

“…Contrasting results emerged from the MACHT study, a multicenter, double‐blind, randomized trial that enrolled patients with decompensated cirrhosis on the waiting list for LT . The full analysis set included 173 patients who received SMT plus either albumin (40 g/15 days), plus midodrine (15 mg/day, elevated to 30 mg/day if the increase in mean arterial pressure with respect to baseline values was <10 mm Hg), or the respective placebos.…”

Section: Available Evidence On the Effects Of Longterm Albumin Adminimentioning

confidence: 99%

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Pro: The Role of Albumin in Pre–Liver Transplant Management

2019

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The wait‐list mortality of patients with decompensated cirrhosis awaiting liver transplantation remains elevated due to the occurrence of complications. Etiologic treatments improve patient survival and lower the incidence of complications when applied in compensated cirrhosis, but a decompensated disease does not improve or even progress despite a response to therapy in a substantial number of patients. Thus, disease‐modifying treatments that reduce the incidence of complications and improve survival are most needed. Such treatments should be able to counteract one or possibly more pathophysiological mechanisms and thus lead to the proinflammatory and pro‐oxidant milieu that characterizes decompensated cirrhosis. In this respect, albumin represents a potentially ideal agent. In fact, besides its ability to expand plasma volume, albumin possesses nononcotic properties, exerting potent antioxidant and immune‐modulating effects. Recent studies have assessed the effect of longterm albumin administration in decompensated cirrhosis. Although the results of these studies may appear conflicting, their analyses suggest that albumin, if given in a sufficient amount and for a sufficient duration, can significantly reduce the incidence of life‐threatening complications of cirrhosis and patient mortality. For these reasons, we favor albumin administration to patients with decompensated cirrhosis wait‐listed for liver transplantation.

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Section: Available Evidence On the Effects Of Longterm Albumin Adminimentioning

confidence: 98%

Section: Available Evidence On the Effects Of Longterm Albumin Adminimentioning

confidence: 99%

Pro: The Role of Albumin in Pre–Liver Transplant Management

2019

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“…There was no difference between the groups, for survival on the waiting list for the complications of cirrhosis or control of ascites. 5 However, rapid access to LT (median treatment 80 days in both groups) may have prevented this trial from more significant results.…”

Section: New Therapeutics In Patients Without Refractory Ascites: Amentioning

confidence: 99%

Optimal management of ascites

Rudler

Mallet

Sultanik

et al. 2020

Liver International

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Ascites is the most common complication of cirrhosis, which develops in 5%‐10% of patients per year. Its management is based on symptomatic measures including restriction of sodium intake, diuretics and paracentesis. Underlying liver disease must always be treated and may improve ascites. In some patients, ascites is not controlled by medical therapies and has a major impact on quality of life and survival. TIPS placement and liver transplantation must therefore be discussed. More recently, repeated albumin infusions and Alfapump® have emerged as new therapies in ascites. In this review, the current data on these different options are analysed and an algorithm to help the physician make clinical decisions is suggested.

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“…Trials in patients with advanced liver disease are extremely challenging and gaining equipoise over which alternative fluid to use would be difficult. The Barcelona group has demonstrated that a placebo‐controlled trial of HAS against normal saline is possible . Although this study randomized 196 patients, Kütting et al in their meta‐analysis, which included 1277 patients, calculated that at least 1550 additional patients need to be recruited in order to detect or disprove a 25% mortality effect for the use of albumin in LVP .…”

Section: Reversing Immune Dysfunctionmentioning

confidence: 99%

“…Albumin has also been reported to have beneficial immunomodulatory and endothelial effects and, therefore, may have a particular beneficial role in sepsis . Finally, 2 trials have been published this year regarding outpatient infusions …”

mentioning

confidence: 99%

Con: The Unclear Benefit of Albumin

O’Brien

2019

Liver Transpl

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Many studies have shown that 20% human albumin solution infusions improve circulatory function in patients with advanced liver disease, and this treatment is widely recommended and used by all hepatologists. However, it is more expensive than other crystalloids or colloids, and several countries suffer shortages of supply. This article examines whether other fluids might be considered for these patients.

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Midodrine and albumin for prevention of complications in patients with cirrhosis awaiting liver transplantation. A randomized placebo-controlled trial

Cited by 169 publications

References 40 publications

Pro: The Role of Albumin in Pre–Liver Transplant Management

Pro: The Role of Albumin in Pre–Liver Transplant Management

Optimal management of ascites

Con: The Unclear Benefit of Albumin

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