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RECRUITING
NCT05148286
PHASE4

Albumin and Crystalloid Administration in Septic Shock

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2426

Start Date

2022-01-17

Completion Date

2026-12-31

Last Updated

2025-07-02

Healthy Volunteers

No

Conditions

Interventions

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