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Albumin and Crystalloid Administration in Septic Shock

Study acronym: ALCAMIST
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Sep 30, 2026 to Sep 30, 2027
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    v8
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary completion date: Sep 30, 2025 to Sep 30, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v6
  4. Notable Primary completion date: Sep 30, 2024 to Sep 30, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v5
  5. Minor Collaborators: 9 to 8v4
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2022 to Jan 17, 2022
    • Site details revised
    v3
  2. Notable Start date: Dec 1, 2021 to Jan 1, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05148286
Lead Sponsor Asan Medical Center
Collaborators: Samsung Medical Center, Gangnam Severance Hospital, Chungnam National University Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Hanyang University, Korea University Ansan Hospital
Conditions
(from sponsor)
Septic Shock
Related terms Shock, Septic
Enrollment 2,426 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov