Albumin and Crystalloid Administration in 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.

Conditions

• Septic Shock

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.

Sponsors & Collaborators

• Samsung Medical Center

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Korea University Ansan Hospital

  collaborator OTHER

• Asan Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-17

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• South Korea

Study Locations