Health TrialsbyHealthPanel

Albumin and Crystalloid Administration in Septic Shock

ConditionSeptic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsan Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treatment

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

2,426 Participants
are divided into 2 treatment groups
Group A: TreatmentActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day all-cause mortality

The 28-day all-cause mortality in septic shock patient after admission will be evaluated

Time frame
28-days

Secondary outcomes

1

90-day all-cause mortality

All-cause death within 90 days

Time frame
90 days
2

ICU mortality

All-cause death during ICU admission

Time frame
28 days
3

Hospital mortality

All-cause death during hospitalization

Time frame
28 days
4

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.

Time frame
28 days

Other outcomes

Sponsors and contacts

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Asan Medical Center

Lead sponsor

Samsung Medical Center

Collaborator

Gangnam Severance Hospital

Collaborator

Chungnam National University Hospital

Collaborator

Seoul National University Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Hanyang University

Collaborator

Korea University Ansan Hospital

Collaborator

Source ClinicalTrials.gov
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