RecruitingPhase 4NCT05148286

Albumin and Crystalloid Administration in Septic Shock

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

Sponsor

Asan Medical Center

Enrollment

2,426 participants

Start Date

Jan 17, 2022

Study Type

INTERVENTIONAL

Conditions

Septic Shock

Summary

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

Min Age: 18 Years

Inclusion Criteria2

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.

Exclusion Criteria8

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
patients who have known hypersensitivity to albumin
Clinical conditions, where albumin administration may be unfavorable (e.g. pulmonary edema, congestive heart failure, traumatic brain injury)
lactation
patients who do not voluntarily consent to participate in the trial.

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Interventions

DRUGTreatment

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. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline.

DRUGPlacebo

For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline.