Albumin Replacement Therapy in Septic Shock

Launched by JENA UNIVERSITY HOSPITAL · Mar 8, 2019

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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