Septic ShockPhase 4ALCAMISTNCT05148286
Albumin and Crystalloid Administration in Septic Shock
A Phase 4 study testing Treatment in people with Septic Shock, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,426 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2022to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Won Young Kim, PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Won Young Kim, MD,PhD, +82-2-3010-3350, wonpia73@naver.com
About this study
Official title: Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial
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.
Read the detailed description
Sepsis is a leading cause of mortality worldwide, contributing to an estimated 11 million deaths in 2017-or 20% of all global deaths. Due to recent advances in the medical management and treatment of sepsis, the mortality of sepsis has been declined in these years, but still stayed at a high level. From 2004, the Surviving Sepsis Campaign (SSC) suggested a protocolized bundle therapy to facilitate implementation at the bedside with a defined target. Recent guideline states that this resuscitation bundle treatment should be initiated within 1 h of the emergency department (ED) triage time, named as 1-h bundle.
Fluid resuscitation, which is the mainstay of treatment to restore a patient's tissue perfusion, is associated with outcome in emergency department patients. The current guideline recommends that crystalloid for initial fluid resuscitation in sepsis and albumin can be additionally administered when patients require substantial amounts of crystalloid. Besides its oncotic functions to provide adequate intravascular volume, albumin has several beneficial properties for sepsis patients, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism. In 2004, a large randomized, prospective, double-blind study was performed in 7000 critically ill patients (SAFE study) to evaluate the effect of volume replacement therapy with human albumin on the outcome compared to only crystalloid. Although the survival rates were similar between the groups, a post hoc analysis of 1218 patients with severe sepsis showed improved survival in the albumin group compared to crystalloid alone. Furthermore, the ALBumin Italian Outcome Sepsis (ALBIOS) study investigated the effect of albumin administration and maintenance of serum albumin concentrations to at least 30 g/l on outcome in patients with severe sepsis and septic shock. This study showed a similar result to SAFE study that no difference on the outcome between the groups. Nevertheless, in the 1121 patients with septic shock, 90-day mortality was lower in the albumin group (564 patients) than in the non-albumin group (43.6 vs. 49%, p = 0.03). Recently, a retrospective study which evaluated the effect of administration of albumin combined with crystalloids in septic patients showed improved survival in 28 days. Therefore, accumulating evidence suggests that early albumin administration may provide a survival benefit in patients with severe and advanced sepsis. However, no prospective, randomized trial has adequately studied this hypothesis in patients with septic shock.
The aim of the ALCAMIST (ALbumin and Crystalloid AdMinistration In SepTic shock) study is to investigate the effect of albumin and crystalloid administration as an initial fluid choice in septic shock compared to crystalloid alone on patient survival.
- Conditions
- Septic Shock
- Being tested
- Treatment, Placebo
- Keywords
- Septic shock, Fluid resuscitation, Albumin, Crystalloid
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
Also called Albumin and crystalloid
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. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline.
PlaceboDrug
Also called Crystalloid only
For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 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. Receives: Drug: Treatment |
| Control | Placebo comparator | For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
The 28-day all-cause mortality in septic shock patient after admission will be evaluated
Measured: 28-days
Secondary outcomes (13)
90-day all-cause mortality
All-cause death within 90 days
Measured: 90 days
ICU mortality
All-cause death during ICU admission
Measured: 28 days
Hospital mortality
All-cause death during hospitalization
Measured: 28 days
The Sequential organ Failure Assessment (SOFA) score
The SOFA score will be recorded daily up to 28 days after randomization. Death within 72 hours will be counted as the maximum SOFA score.
Measured: 28 days
Intensive Care Unit (ICU) stay
The total length of ICU stay will be determined from the date of ICU admission until the patient is discharged from the ICU or the date of death from any cause, assessed up to 90 days after the first day of admission.
Measured: 90 days
7-day mortality
All-cause death within 7 days
Measured: 7 days
Ventilator free days
Days without ventilator within 28 days from admission
Measured: 28 days
Vasopressor free days
Days without vasopressor within 28 days from admission
Measured: 28 days
Total amount of fluid administration
Total amount of fluid administration during hospital admission
Measured: 3 day, 7 day, 28 day
Total fluid balance
Fluid balance will be recorded daily up to 28 days after randomization
Measured: 28 days
Maximum dose of vasopressor use
Maximum dose of vasopressor during hospital admission
Measured: 28 days
Renal replacement therapy
Whether renal replacement therapy was initiated during hospital admission after randomization.
Measured: 28 days
Safety-related parameters
Occurrence of adverse event, serious adverse event (e.g. anaphylactic shock, hypervolemia, pulmonary edema)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start17 Jan 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Won Young Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148286
- Sponsor's protocol ID
- ALCAMIST trial
- Acronym
- ALCAMIST
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05148286
- Acronym / sponsor ID
- ALCAMIST / ALCAMIST trial
- Conditions
- Septic Shock
- Keywords
- Septic shock, Fluid resuscitation, Albumin, Crystalloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,426 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- 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
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sepsis is a leading cause of mortality worldwide, contributing to an estimated 11 million deaths in 2017-or 20% of all global deaths. Due to recent advances in the medical management and treatment of sepsis, the mortality of sepsis has been declined in these years, but still stayed at a high level. From 2004, the Surviving Sepsis Campaign (SSC) suggested a protocolized bundle therapy to facilitate implementation at the bedside with a defined target. Recent guideline states that this resuscitation bundle treatment should be initiated within 1 h of the emergency department (ED) triage time, named as 1-h bundle.
Fluid resuscitation, which is the mainstay of treatment to restore a patient's tissue perfusion, is associated with outcome in emergency department patients. The current guideline recommends that crystalloid for initial fluid resuscitation in sepsis and albumin can be additionally administered when patients require substantial amounts of crystalloid. Besides its oncotic functions to provide adequate intravascular volume, albumin has several beneficial properties for sepsis patients, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism. In 2004, a large randomized, prospective, double-blind study was performed in 7000 critically ill patients (SAFE study) to evaluate the effect of volume replacement therapy with human albumin on the outcome compared to only crystalloid. Although the survival rates were similar between the groups, a post hoc analysis of 1218 patients with severe sepsis showed improved survival in the albumin group compared to crystalloid alone. Furthermore, the ALBumin Italian Outcome Sepsis (ALBIOS) study investigated the effect of albumin administration and maintenance of serum albumin concentrations to at least 30 g/l on outcome in patients with severe sepsis and septic shock. This study showed a similar result to SAFE study that no difference on the outcome between the groups. Nevertheless, in the 1121 patients with septic shock, 90-day mortality was lower in the albumin group (564 patients) than in the non-albumin group (43.6 vs. 49%, p = 0.03). Recently, a retrospective study which evaluated the effect of administration of albumin combined with crystalloids in septic patients showed improved survival in 28 days. Therefore, accumulating evidence suggests that early albumin administration may provide a survival benefit in patients with severe and advanced sepsis. However, no prospective, randomized trial has adequately studied this hypothesis in patients with septic shock.
The aim of the ALCAMIST (ALbumin and Crystalloid AdMinistration In SepTic shock) study is to investigate the effect of albumin and crystalloid administration as an initial fluid choice in septic shock compared to crystalloid alone on patient survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: TreatmentFor 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. |
| Control | Placebo comparator | Drug: PlaceboFor the control group, 30 cc per kg of crystalloid will be administered according to the usual practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentAlso: Albumin and crystalloidFor 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. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline. | Drug | Treatment |
| PlaceboAlso: Crystalloid onlyFor the control group, 30 cc per kg of crystalloid will be administered according to the usual practice. The treating physicians can choose the type of fluid, such as balanced fluid or isotonic saline. | Drug | Control |
Primary outcome
28-day all-cause mortality
Time frame: 28-days
The 28-day all-cause mortality in septic shock patient after admission will be evaluated
13 secondary outcomes
90-day all-cause mortality
Time frame: 90 days
ICU mortality
Time frame: 28 days
Hospital mortality
Time frame: 28 days
The Sequential organ Failure Assessment (SOFA) score
Time frame: 28 days
Intensive Care Unit (ICU) stay
Time frame: 90 days
7-day mortality
Time frame: 7 days
Ventilator free days
Time frame: 28 days
Vasopressor free days
Time frame: 28 days
Total amount of fluid administration
Time frame: 3 day, 7 day, 28 day
Total fluid balance
Time frame: 28 days
Maximum dose of vasopressor use
Time frame: 28 days
Renal replacement therapy
Time frame: 28 days
Safety-related parameters
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Won Young Kim, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment in people with Septic Shock, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang-Min Kim, Dr. (82-10-3010-0730, swdarkhorse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.