Albumin and Crystalloid Administration in Septic Shock

ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsan Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (≥ 18 years) who visit an ED directly and are suspected of sepsis with shock

Shock is defined as hypotension (mean arterial blood pressure (MAP) < 65 or systolic blood pressure < 80) and tissue hypoperfusion such as an initial serum lactate level ≥ 4 mmol/dL.

Disqualifiers

patients who are transferred from another hospital after initial fluid administration

patients who have set limitations on treatment (e.g. patients with a signed do-not-resuscitate order)

patients with moribund conditions with life expectancy less than 28 days due to secondary diseases or advanced malignant disease and palliative situations with life expectancy less than 6 months

patients who have been administered albumin before enrollment

Trial design

Treatments tested in this trial

  • Treatment
  • Placebo

Treatment groups

2,426 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Asan Medical Center

Lead sponsor

Samsung Medical Center

Collaborator

Gangnam Severance Hospital

Collaborator

Chungnam National University Hospital

Collaborator

Seoul National University Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Hanyang University

Collaborator

Korea University Ansan Hospital

Collaborator