Septic Shock MedDRA version: 20.0 Level: LLT Classification code 10001559 Term: Albumin abnormal System Organ Class: 100000004848 MedDRA version: 21.0 Level: LLT Classification code 10035167 Term: Plasma albumin abnormal System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Albutein 200 g/l, Infusionslösung
Product Name: Albutein 200g/l
Pharmaceutical Form: Infusion
INN or Proposed INN: Albumin (human)
Other descriptive name: ALBUMIN
Concentration unit: g/l g
Sponsors
Friedrich-Schiller-Universität Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the following inclusion criteria may be included in this clinical trial: 1) Presence of septic shock that meets all the following criteria: o Clinically possible, probable or microbiologically confirmed infection in accordance with the definitions of the "International Sepsis Forum (ISF)" o Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) = 65 mm Hg for at least 1 hour o Serum lactate concentration > 2 mmol/l (18 mg/dl) despite adequate volume therapy 2) Onset of septic shock less than 24 hours prior to study inclusion, so that administration of the initial dose of the trial product is possible within 6-24 hours after the onset of septic shock in the albumin group 3) Age: = 18 years 4) Written informed consent of the patient or his/her legal representative (guardian) or confirmation of the urgency of participation in the clinical trial and the 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 5) Patient of childbearing age: negative pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 412
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria cannot be included in the trial: 1) 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 2) "End of life" decisions made before obtaining informed consent: "Do Not Resuscitate (DNR)" and "Withhold/Withdraw Life-Sustaining measures" 3) Previous participation in the study 4) Participation in another interventional clinical trial within the past 3 months 5) States of shock that are explainable by other causes, e.g. cardiogenic shock, anaphylactic shock, neurogenic shock 6) History of hypersensitivity to albumin or any other component of the trial product, e.g., sodium caprylate, sodium N-acetyltryptophanate 7) Disease in which the use of albumin may be deleterious, e.g., decompensated heart failure or traumatic brain injury 8) Disease situations in which albumin administration may be advantageous, e.g., hepatorenal syndrome, nephrosis, burns, and intestinal malabsorption syndrome 9) Lactation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) 28- and 60-day mortality, 2) ICU and hospital mortality, 3) organ dysfunction/failure as assessed by the SOFA-Score: recorded daily up to 28 days in the ICU after randomisation in the study, 4) ICU and hospital lengths of stay, 5) ventilator- and vasopressor-free days, 6) cost-benefit of volume replacement therapy: collection of data on the use of human albumin and other colloids and crystalloids, 7) total fluid intake and total fluid balance, and 8) safety-related parameters: occurrence of AEs and SAEs, especially anaphylactic shock, hypervolaemia, and pulmonary oedema.;Timepoint(s) of evaluation of this end point: 1) 28- and 60-day after randomisation 2) ICU and hospital discharge 3) Daily up to 28 days in the ICU after randomisation in the study | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether albumin administration and maintenance of serum albumin concentrations of at least 30 g/L in the ICU for up to 28 days after the onset of septic shock, will reduce total 90-day mortality compared to volume replacement therapy without albumin;Secondary Objective: - To investigate whether albumin administration and maintenance of serum albumin concentrations of at least 30 g/L in the ICU for up to 28 days after the onset of septic shock would influence ICU, hospital, 28- and 60-day mortality rates, rates of organ dysfunction/failure as assessed by the SOFA score, ICU/hospital lengths of stay, ventilator and vasopressor-free days. - Cost-benefit analysis of volume replacement therapy from ICU admission until maximum day 28;Primary end point(s): The primary endpoint is 90-day all-cause mortality;Timepoint(s) of evaluation of this end point: 90-day after randomisation | — |
Countries
Germany
Contacts
Public ContactCenter for Clinical Studies
Universitätsklinikum Jena, Zentrum für Klinische Studien
Outcome results
None listed