RecruitingPhase 4

Albumin and Crystalloid Administration in Septic Shock

South Korea2,426 participantsStarted 2022-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

28-day all-cause mortality

Timeframe: 28-days

Trial details

NCT IDNCT05148286

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Sang-Min Kim, Dr.

82-10-3010-0730 swdarkhorse@gmail.com

View on ClinicalTrials.gov More Septic Shock trials