Actively Recruiting
Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial
Led by Asan Medical Center · Updated on 2025-07-02
2426
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Septic shock is a serious condition with high mortality worldwide, and fluid resuscitation is a key part of its initial treatment. Researchers are investigating whether adding albumin to crystalloid fluids early in treatment improves survival compared to using crystalloids alone. This trial aims to assess this approach in patients with septic shock, building upon previous studies that showed possible survival benefits but lacked definitive randomized evidence. Participants will be randomly assigned to one of two groups. The treatment group will receive 200cc of 20% human albumin combined with 15 cc per kg of crystalloid fluid over 1 to 2 hours. The control group will receive 30 cc per kg of crystalloid fluid alone, following usual care practices. Physicians may choose the type of crystalloid fluid, such as balanced fluids or isotonic saline. This study is open-label and multi-center, designed to compare these two fluid resuscitation strategies. During the study, participants will be monitored for survival at 28 days, which is the primary outcome. Additional assessments include mortality at 7 and 90 days, ICU and hospital mortality, organ function scores, ICU stay length, ventilator and vasopressor use, fluid balance, renal therapy need, and safety parameters. Follow-up will take place over several time points up to 90 days. The total duration of participation depends on these monitoring periods and clinical evaluations.
CONDITIONS
Brief Title
Albumin and Crystalloid Administration in Septic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older who visit an emergency department directly and are suspected of sepsis with shock
- Shock defined as low blood pressure (mean arterial pressure under 65 or systolic blood pressure under 80) and tissue hypoperfusion such as an initial serum lactate level of 4 mmol/dL or higher
You will not qualify if you...
- Patients transferred from another hospital after initial fluid administration
- Patients with treatment limitations such as do-not-resuscitate orders
- Patients with life expectancy less than 28 days due to other diseases or advanced cancer, or palliative situations with life expectancy less than 6 months
- Patients who have received albumin before enrollment
- Patients with known hypersensitivity to albumin
- Conditions where albumin may be harmful, including pulmonary edema, congestive heart failure, or traumatic brain injury
- Lactating patients
- Patients who do not voluntarily consent to participate in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 hours
Participants receive initial fluid resuscitation with either albumin combined with crystalloid or crystalloid alone as part of their treatment for septic shock.
1 treatment visit (in-person)
Duration - Up to 90 days
Participants are monitored for outcomes including survival and organ function up to 90 days after treatment.
Multiple follow-up visits up to 90 days
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
S
Sang-Min Kim, Dr.
W
Won Young Kim, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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