NCT05148286

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,426

participants targeted

Target at P75+ for phase_4

Timeline
8mo left

Started Jan 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2022Dec 2026

First Submitted

Initial submission to the registry

November 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

4.7 years

First QC Date

November 25, 2021

Last Update Submit

June 30, 2025

Conditions

Septic Shock

Keywords

Septic shockFluid resuscitationAlbuminCrystalloid

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

    The 28-day all-cause mortality in septic shock patient after admission will be evaluated

    28-days

Secondary Outcomes (13)

  • 90-day all-cause mortality

    90 days

  • ICU mortality

    28 days

  • Hospital mortality

    28 days

  • The Sequential organ Failure Assessment (SOFA) score

    28 days

  • Intensive Care Unit (ICU) stay

    90 days

  • +8 more secondary outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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.

Drug: Treatment

Control

PLACEBO COMPARATOR

For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice.

Drug: Placebo

Interventions

TreatmentDRUG

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.

Also known as: Albumin and crystalloid
Treatment
PlaceboDRUG

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.

Also known as: Crystalloid only
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

TherapeuticsAlbuminsCrystalloid Solutions

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Sang-Min Kim, Dr.

CONTACT

82-10-3010-0730swdarkhorse@gmail.com

Won Young Kim, PhD

CONTACT

wonpia73@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 8, 2021

Study Start

January 17, 2022

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)