NCT05148286 Albumin and Crystalloid Administration in Septic Shock
| NCT ID | NCT05148286 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Asan Medical Center |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,426 participants |
| Start Date | 2022-01-17 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,426 participants in total. It began in 2022-01-17 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05148286 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05148286 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05148286 currently recruiting?
Yes, NCT05148286 is actively recruiting participants. Contact the research team at swdarkhorse@gmail.com for enrollment information.
Where is the NCT05148286 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05148286 clinical trial?
NCT05148286 is sponsored by Asan Medical Center. The trial plans to enroll 2,426 participants.