Using albumin and crystalloid fluids to treat septic shock
Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial
This study tests if giving albumin along with regular fluids can help adults with septic shock survive better than the usual treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2426 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05148286 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of early administration of albumin combined with crystalloid fluids for the treatment of septic shock. The study aims to determine if this approach improves survival rates compared to standard resuscitation methods that do not include albumin. Adult patients suspected of having septic shock will be enrolled directly from the emergency department and monitored for outcomes related to fluid resuscitation. The trial builds on previous findings suggesting that albumin may offer additional benefits in managing sepsis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present to the emergency department with suspected septic shock.
Not a fit: Patients with advanced malignancies, those with do-not-resuscitate orders, or individuals who have previously received albumin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients suffering from septic shock.
How similar studies have performed: Previous studies have indicated potential survival advantages with albumin administration in septic shock, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Sang-Min Kim, Dr.
- Email: swdarkhorse@gmail.com
- Phone: 82-10-3010-0730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.