Status:
TERMINATED
Albumin Replacement Therapy in Septic Shock
Lead Sponsor:
Jena University Hospital
Collaborating Sponsors:
German Research Foundation
Instituto Grifols, S.A.
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 mole...
Detailed 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 ...
Eligibility Criteria
Inclusion
- The presence of septic shock meeting all of the following criteria:
- Clinically possible or probable or microbiologically confirmed infection taking into account the definitions of the "International Sepsis Forum (ISF)"
- Despite adequate volume therapy, vasopressors are required to maintain mean arterial 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 dose of the trial drug in the albumin group will be possible within 6-24 hours after the start of the septic shock
- Age: ≥ 18 years
- Written informed consent of the patient or his/her legal representative or confirmation of the urgency of participation in the clinical trial and possible benefit to the patient by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing centre to include patients who are unable to provide informed consent in whom subsequent consent may be obtained retrospectively.
- Patients of childbearing age: negative pregnancy test
Exclusion
- Moribund conditions with life expectancy less than 28 days because of comorbid conditions or advanced malignant disease and palliative situations with life expectancy less than 6 months
- Presence of an "end of life" decision prior to obtaining informed consent: "Do Not Resuscitate (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., decompensated heart failure or traumatic brain injury
- Clinical conditions where albumin administration is indicated, e.g., hepatorenal syndrome, nephrosis, burns, intestinal malabsorption syndrome
- Lactation
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT03869385
Start Date
October 21 2019
End Date
June 13 2023
Last Update
October 28 2024
Active Locations (27)
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1
Klinikum Augsburg, Klinik für Anästhesiologie und Operative Intensivmedizin
Augsburg, Germany, 86156
2
Helios Klinikum Bad Saarow, Klinik für Intensivmedizin
Bad Saarow, Germany, 15526
3
Vivantes Humboldt Klinikum, Klinik für Innere Medizin, Kardiologie und konservative Intensivmedizin
Berlin, Germany, 13509
4
Universitätsklinikum Bonn, Klinik für Anästesiologie und Operative Intensivmedizin
Bonn, Germany, 53105