Albumin Replacement Therapy in Septic Shock

Last updated: October 25, 2024
Sponsor: Jena University Hospital
Overall Status: Terminated

Phase

3

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

Albutein® 200 g/L or Plasbumin® 20

Clinical Study ID

NCT03869385
ZKSJ0112_ARISS
SA 2167/3-1, Nr: 328809707
2018-001874-89
ZKSJ0112
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The presence of septic shock meeting all of the following criteria:

  • Clinically possible or probable or microbiologically confirmed infection takinginto account the definitions of the "International Sepsis Forum (ISF)"

  • Despite adequate volume therapy, vasopressors are required to maintain meanarterial pressure (MAP) ≥ 65 mm Hg for at least 1 hour

  • Serum lactate level > 2 mmol/l (18 mg/dl) despite adequate volume therapy

  • Start of septic shock less than 24 hours prior to inclusion, so that the start doseof the trial drug in the albumin group will be possible within 6-24 hours after thestart of the septic shock

  • Age: ≥ 18 years

  • Written informed consent of the patient or his/her legal representative orconfirmation of the urgency of participation in the clinical trial and possiblebenefit to the patient by an independent consultant or the implementation of otherestablished procedures according to the local regulations of the contributing centreto include patients who are unable to provide informed consent in whom subsequentconsent may be obtained retrospectively.

  • Patients of childbearing age: negative pregnancy test

Exclusion

Exclusion Criteria:

  • Moribund conditions with life expectancy less than 28 days because of comorbidconditions or advanced malignant disease and palliative situations with lifeexpectancy less than 6 months

  • Presence of an "end of life" decision prior to obtaining informed consent: "Do NotResuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures"

  • Previous participation in this study

  • Participation in another interventional clinical trial within the past 3 months

  • Shock states that can be explained by other causes, e.g. cardiogenic shock,anaphylactic shock, neurogenic shock

  • History of hypersensitivity to albumin or any other component of the trial drug,e.g., B., sodium caprylate, sodium N-acetyltryptophanate

  • Diseases in which albumin administration may be deleterious, e.g., decompensatedheart failure or traumatic brain injury

  • Clinical conditions where albumin administration is indicated, e.g., hepatorenalsyndrome, nephrosis, burns, intestinal malabsorption syndrome

  • Lactation

Study Design

Total Participants: 440
Treatment Group(s): 1
Primary Treatment: Albutein® 200 g/L or Plasbumin® 20
Phase: 3
Study Start date:
October 21, 2019
Estimated Completion Date:
June 13, 2023

Study Description

This is a prospective, multicentre, randomised, controlled, parallel-grouped, open-label, interventional clinical trial in which 1662 patients are planned to be allocated. Subjects will be randomized in a 1:1 ratio to receive either Albumin or routine treatment with crystalloids. Treatment will be continued at maximum for 28 days or until the patient leaves the ICU. Primary endpoint measurement will be carried out 90 days after randomisation

Connect with a study center

  • Klinikum Augsburg, Klinik für Anästhesiologie und Operative Intensivmedizin

    Augsburg, 86156
    Germany

    Site Not Available

  • Helios Klinikum Bad Saarow, Klinik für Intensivmedizin

    Bad Saarow, 15526
    Germany

    Site Not Available

  • Vivantes Humboldt Klinikum, Klinik für Innere Medizin, Kardiologie und konservative Intensivmedizin

    Berlin, 13509
    Germany

    Site Not Available

  • Universitätsklinikum Bonn, Klinik für Anästesiologie und Operative Intensivmedizin

    Bonn, 53105
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen, Anästesiologische Klinik

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie, Chir. Intensivstation

    Freiburg, 79106
    Germany

    Site Not Available

  • Universitätsmedizin Greifswald, Klinik für Anästhesiologie, Intensiv-, Notfall- und Schmerzmedizin

    Greifswald, 17475
    Germany

    Site Not Available

  • Universitätsmedizin Göttingen, Klinik für Anästhesiologie, Rettungs- und Intensivmedizin

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg, Klinik für Anästhesiologie

    Heidelberg, 69120
    Germany

    Site Not Available

  • Klinikum Herford, Medizinische Klinik III, Kardiologie

    Herford, 32049
    Germany

    Site Not Available

  • Marien Hospital Herne, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Anästhesiologie, Operative Intensivmedizin, Schmerztherapie, Palliativmedizin

    Herne, 44625
    Germany

    Site Not Available

  • Universitätsklinikum des Saarlandes, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie

    Homburg, 66421
    Germany

    Site Not Available

  • Universitätsklinikum Jena, Innere Medizin I, Kardiologie

    Jena, 07747
    Germany

    Site Not Available

  • Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie

    Jena, 07747
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein, Klinik für Operative Intensivmedizin

    Kiel, 24105
    Germany

    Site Not Available

  • St. Elisabeth Krankenhaus, Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerztherapie

    Köln, 50935
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Interdisziplinäre Internistische Intensivmedizin

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik für Anästhesiologie u. Intensivtherapie

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg, Klinik für Anästhesiologie und Intensivmedizin

    Magdeburg,
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg, Klinik für Innere Medizin, Kardiologie und Angiologie

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitätsklinikum der Johannes-Gutenberg-Universität Mainz, Klinik für Anästhesiologie

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum der LMU München, Klinik für Anästhesiologie

    München, 81377
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TU München, Klinik für Anästhesiologie und Intensivmedizin

    München, 81675
    Germany

    Site Not Available

  • Universitätsklinikum Münster, Klinik für Anästesiologie, operative Intensivmedizin und Schmerztherapie

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Chirurgie

    Regensburg, 93053
    Germany

    Site Not Available

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