Albumin and Crystalloid Administration in Septic Shock
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Septic Shock
In brief
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.
Key facts
- Study ID
- NCT05148286
- Run by
- Asan Medical Center
- People needed
- 2426
- Starts
- 2022-01-17
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Asan Medical Center — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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