Albumin is a key regulator of fluid distribution within the extracellular space and possesses
several properties beyond its oncotic activity, including binding and transport of several
endogenous molecules, anti-inflammatory and anti-oxidant actions, nitric oxide modulation,
and buffer function. The accumulating evidence suggests that supplementation of albumin may
provide survival advantages only when the insult is severe as in patients with septic shock.
Prospective randomized trials on the possible impact of albumin replacement in these patients
with septic shock are lacking. The aim of the study is to investigate whether the replacement
with albumin and the maintenance of its serum levels at least at 30 g/l for 28 days improve
survival in patients with septic shock compared to resuscitation and volume maintenance
without albumin. In this prospective, multicenter, randomised trial, adult patients (≥18
years) with septic shock will be randomly assigned within a maximum of 24 hours after the
onset of septic shock after obtaining informed consents to treatment or control groups.
Patients assigned to the treatment group will receive a 60 g loading dose of human albumin
20% over 2-3 hours. Serum albumin levels will be maintained at least at 30 g/l in the ICU for
a maximum of 28 days following randomization using 40-80 g human albumin 20% infusion. The
control group will be treated according to the usual practice with crystalloids as the first
choice for the resuscitation and maintenance phase of septic shock. The primary end point is
90 days mortality and secondary end points include 28-day, 60-day, ICU, and in-hospital
mortality, organ dysfunction/failure, and length of ICU and hospital stay. In total 1412
patients need to be analyzed, 706 per group. Assuming a dropout rate of 15%, a total of 1662
patients need to be allocated.
Phase:
Phase 3
Details
Lead Sponsor:
Jena University Hospital
Collaborators:
Center for Sepsis Control and Care, Germany German Competence Network Sepsis German Research Foundation Instituto Grifols, S.A. SepNet - Critical Care Trials Group The Center for Clinical Trials (ZKS), Jena University Hospital Goettingen