Efficacy of Albumin Replacement and Balanced Solution in Patients with Septic Shock (the ALBIOSS-BALANCED trial): a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial
Acronimo
ALBIOSS-BALANCED
Codice Istituto
287
Ruolo Istituto
PARTNER
Stato Studio
Completed
Patologia
Other shock
Tipo intervento
Pharmacological - Phase 3
Parole Chiave
balanced crystalloid solutions, albumin, septic shock
Farmaco
albumin, balanced crystalloid solutions
Scopo dello studio
Testing the efficacy of albumin and the low-chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol - BAL) in septic shock
Descrizione dello studio
Septic shock is a devastating condition often observed in ICU. It is characterized by pro-inflammatory and immune responses, organ failures, high incidence of AKI and lethality. Fluid resuscitation is pivotal as supportive therapy. At present, there are no effective therapies to improve survival of such clinical condition, often characterized by a mortality as high as 40% during the first 90 days from diagnosis.
This project proposes a large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low-chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol – BAL) in septic shock.
We have recently concluded a multicenter, randomized trial, the ALBIOS trial, in which, in a post-hoc analysis, albumin, in addition to crystalloids, reduced 90-day mortality in patients with septic shock, as compared to crystalloids alone (Caironi P et al, 2014). Crystalloids with supra-physiological chloride content may deteriorate renal perfusion, increasing the risk of acute kidney injury (AKI) and mortality.
Profilo scientifico
Tipo studio
EXPERIMENTAL
Tipo disegno
Randomized, Open label
Tipo braccio controllo
Multi-control
Conduzione studio
Multicenter National
Promotore
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Tipo promotore
No-profit
Contatto
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Clinical Trials