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

Who is this study for? Patients with Septic Shock
What treatments are being studied? Albumin+Crystalloid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Sang-Min Kim, Dr.
swdarkhorse@gmail.com
82-10-3010-0730
Backup
Won Young Kim, PhD
wonpia73@naver.com
Time Frame
Start Date: 2022-01-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2426
Treatments
Active_comparator: 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.
Placebo_comparator: Control
For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice.
Related Therapeutic Areas
Sponsors
Collaborators: Seoul National University Bundang Hospital, Seoul National University Hospital, Samsung Medical Center, SMG-SNU Boramae Medical Center, Korea University Ansan Hospital, Chungnam National University Hospital, Hanyang University, Gangnam Severance Hospital
Leads: Asan Medical Center

This content was sourced from clinicaltrials.gov