Albumin and Crystalloid Administration in Septic Shock

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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. We 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Chungnam National University Hospital; Gangnam Severance Hospital; Hanyang University; Korea University; Korea University Guro Hospital; Samsung Medical Center; Seoul National University Bundang Hospital; Seoul National University Hospital; SMG-SNU Boramae Medical Center

Criteria

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.