The current guideline emphasizes fluid resuscitation as the mainstay of initial management
      for septic shock. Albumin has the oncotic activity to maintain intravascular volumes with
      additional beneficial properties in sepsis. Prior studies showed that the replacement of
      albumin might have survival advantages in patients with septic shock. The investigators aim
      to assess whether the early administration of albumin with crystalloid as initial fluid
      resuscitation improves survival in patients with septic shock compared to resuscitation
      without albumin.

Albumin and Crystalloid Administration in Septic Shock

Septic Shock

Sepsis is a leading cause of mortality worldwide, contributing to an estimated 11 million
      deaths in 2017-or 20% of all global deaths. Due to recent advances in the medical management
      and treatment of sepsis, the mortality of sepsis has been declined in these years, but still
      stayed at a high level. From 2004, the Surviving Sepsis Campaign (SSC) suggested a
      protocolized bundle therapy to facilitate implementation at the bedside with a defined
      target. Recent guideline states that this resuscitation bundle treatment should be initiated
      within 1 h of the emergency department (ED) triage time, named as 1-h bundle.

      Fluid resuscitation, which is the mainstay of treatment to restore a patient's tissue
      perfusion, is associated with outcome in emergency department patients. The current guideline
      recommends that crystalloid for initial fluid resuscitation in sepsis and albumin can be
      additionally administered when patients require substantial amounts of crystalloid. Besides
      its oncotic functions to provide adequate intravascular volume, albumin has several
      beneficial properties for sepsis patients, including binding and transport of various
      endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric
      oxide metabolism. In 2004, a large randomized, prospective, double-blind study was performed
      in 7000 critically ill patients (SAFE study) to evaluate the effect of volume replacement
      therapy with human albumin on the outcome compared to only crystalloid. Although the survival
      rates were similar between the groups, a post hoc analysis of 1218 patients with severe
      sepsis showed improved survival in the albumin group compared to crystalloid alone.
      Furthermore, the ALBumin Italian Outcome Sepsis (ALBIOS) study investigated the effect of
      albumin administration and maintenance of serum albumin concentrations to at least 30 g/l on
      outcome in patients with severe sepsis and septic shock. This study showed a similar result
      to SAFE study that no difference on the outcome between the groups. Nevertheless, in the 1121
      patients with septic shock, 90-day mortality was lower in the albumin group (564 patients)
      than in the non-albumin group (43.6 vs. 49%, p = 0.03). Recently, a retrospective study which
      evaluated the effect of administration of albumin combined with crystalloids in septic
      patients showed improved survival in 28 days. Therefore, accumulating evidence suggests that
      early albumin administration may provide a survival benefit in patients with severe and
      advanced sepsis. However, no prospective, randomized trial has adequately studied this
      hypothesis in patients with septic shock.

      The aim of the ALCAMIST (ALbumin and Crystalloid AdMinistration In SepTic shock) study is to
      investigate the effect of albumin and crystalloid administration as an initial fluid choice
      in septic shock compared to crystalloid alone on patient survival.

Treatment

Placebo

Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial

The 28-day all-cause mortality in septic shock patient after admission will be evaluated

Professor

The SOFA score will be recorded daily up to 28 days after randomization. Death within 72 hours will be counted as the maximum SOFA score.

The total length of ICU stay will be determined from the date of ICU admission until the patient is discharged from the ICU or the date of death from any cause, assessed up to 90 days after the first day of admission.

Days without ventilator within 28 days from admission

Days without vasopressor within 28 days from admission

Total amount of fluid administration during hospital admission

Fluid balance will be recorded daily up to 28 days after randomization

Maximum dose of vasopressor during hospital admission

Whether renal replacement therapy was initiated during hospital admission after randomization.

Occurrence of adverse event, serious adverse event (e.g. anaphylactic shock, hypervolemia, pulmonary edema)

For the treatment group, 200cc of 20% human albumin with 15 cc per kg of crystalloid will be administered over 1~2h for initial fluid resuscitation.

For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice.

Albumin and Crystalloid Administration in Septic Shock

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status