RECRUITINGPhase 4INTERVENTIONAL

Albumin and Crystalloid Administration in Septic Shock

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

DRUG

Treatment

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.

DRUG

Placebo

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.

Locations (1)

Asan Medical Center

Seoul, South Korea