- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05148286
Albumin and Crystalloid Administration in Septic Shock (ALCAMIST)
Albumin and Crystalloid Administration in Septic Shock (ALCAMIST): Multi-center, Open Labelled Randomized Controlled Trial
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sang-Min Kim, Dr.
- Phone Number: 82-10-3010-0730
- Email: swdarkhorse@gmail.com
Study Contact Backup
- Name: Won Young Kim, PhD
- Email: wonpia73@naver.com
Study Locations
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-
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Seoul, Korea, Republic of, 05505
- Recruiting
- Asan Medical Center
-
Contact:
- Won Young Kim, MD,PhD
- Phone Number: +82-2-3010-3350
- Email: wonpia73@naver.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment
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.
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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.
Other Names:
|
Placebo Comparator: Control
For the control group, 30 cc per kg of crystalloid will be administered according to the usual practice.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day all-cause mortality
Time Frame: 28-days
|
The 28-day all-cause mortality in septic shock patient after admission will be evaluated
|
28-days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day mortality
Time Frame: 7 days
|
All-cause death within 7 days
|
7 days
|
90-day all-cause mortality
Time Frame: 90 days
|
All-cause death within 90 days
|
90 days
|
ICU mortality
Time Frame: 28 days
|
All-cause death during ICU admission
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28 days
|
Hospital mortality
Time Frame: 28 days
|
All-cause death during hospitalization
|
28 days
|
The Sequential organ Failure Assessment (SOFA) score
Time Frame: 28 days
|
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.
|
28 days
|
Intensive Care Unit (ICU) stay
Time Frame: 90 days
|
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.
|
90 days
|
Ventilator free days
Time Frame: 28 days
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Days without ventilator within 28 days from admission
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28 days
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Vasopressor free days
Time Frame: 28 days
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Days without vasopressor within 28 days from admission
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28 days
|
Total amount of fluid administration
Time Frame: 3 day, 7 day, 28 day
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Total amount of fluid administration during hospital admission
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3 day, 7 day, 28 day
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Total fluid balance
Time Frame: 28 days
|
Fluid balance will be recorded daily up to 28 days after randomization
|
28 days
|
Maximum dose of vasopressor use
Time Frame: 28 days
|
Maximum dose of vasopressor during hospital admission
|
28 days
|
Renal replacement therapy
Time Frame: 28 days
|
Whether renal replacement therapy was initiated during hospital admission after randomization.
|
28 days
|
Safety-related parameters
Time Frame: 28 days
|
Occurrence of adverse event, serious adverse event (e.g.
anaphylactic shock, hypervolemia, pulmonary edema)
|
28 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALCAMIST trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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