Trial document




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  DRKS00017475

Trial Description

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Title

ARISS - Randomised controlled multicentre study of albumin replacement therapy in septic shock

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Trial Acronym

ARISS

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URL of the Trial

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Brief Summary in Lay Language

In an intensive care unit, sepsis is the tenth leading cause of death in industrialized countries. Although the mortality rate has slightly decreased in the last 3 years of the observation period in the analysis of 33815 patients with septic shock, the hospital mortality rate in 2013 was 58.8%. Based on the findings of the SAFE and ALBIOS studies, as well as the specific physiological properties of the blood protein albumin, the current data suggest that albumin administration in severe and advanced sepsis with impairment of the protective effect of serum albumin could provide a survival benefit. So far, there is no prospective, randomized study that adequately investigated this hypothesis in patients with septic shock. The objective of the ARISS clinical trial is to investigate the effect of an albumin dose and the maintenance of an albumin serum value higher than 30 g / L for 28 days after onset of septic shock compared to volume replacement therapy without albumin for patient survival. ARISS is based on the hypothesis that an albumin dose commenced within 6-24 h after the onset of septic shock, and the maintenance of an albumin serum value of at least 30 g / l for 28 days after onset of septic shock, compared to volume replacement therapy without albumin, which will reduce 90-day overall mortality.

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Brief Summary in Scientific Language

Within the ARISS study, patients of both genders ≥ 18 years of age who experience septic shock within 24 hours and are being treated in the intensive care unit (ITS) are included.
To investigate whether after ingestion of septic shock, albumin administration and maintenance of an albumin serum level of at least 30 g / L in intensive care for up to 28 days will reduce total 90-day mortality compared to volume replacement therapy without albumin.

This compares with the standard therapy of septic shock with any crystalloids as a volume replacement therapy of first choice.

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Organizational Data

  •   DRKS00017475
  •   2019/07/08
  •   2019/03/11
  •   yes
  •   Approved
  •   2018-1227, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   2018-001874-89 
  •   NCT03869385   (clinicaltrials.gov)
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Health Condition or Problem studied

  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   The intervention group receives human albumin intravenously. The dose begins with a starting dose of 60 g of human albumin 20% for 2-3 h and is from study day 1 after randomization depending on the albumin serum value:
    ≥ 30 g / l: no administration
    ≥ 25 g / l and <30 g / l: 40 g for 1-2 h
    ≥ 20 g / l and <25 g / l: 60 g for 2-3 h
    <20 g / l: 80 g over 3-4 h
    customized.
    The duration of the application is a maximum of 28 days after randomization.
  •   The control group will receive the standard therapy of septic shock with any crystalloids as volume replacement therapy of first choice.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IIIb
  •   No
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Primary Outcome

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.

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Secondary Outcome

• 28- and 60-day mortality,
• ICU and hospital mortality,
• organ dysfunction/failure as assessed by the SOFA-Score: recorded daily up to 28 days in the ICU after randomisation in the study,
• ICU and hospital lengths of stay,
• ventilator- and vasopressor-free days,
• cost-benefit of volume replacement therapy: collection of data on the use of human albumin and other colloids and crystalloids,
• Total amount of fluid administration and total fluid balance, and
• safety-related parameters: occurrence of AEs and SAEs, especially anaphylactic shock, hypervolaemia, and pulmonary oedema.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/08/26
  •   1662
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

The presence of septic shock meeting all of the following criteria (1):
o Clinically possible or probable or microbiologically confirmed infection according to the definitions of the International-Sepsis-Forums (ISF) (2)
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 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

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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 reasons, e.g. cardiogenic, anaphylactic, and 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

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Addresses

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    • Friedrich-Schiller-Universität Jena
    • Bachstr. 18
    • 07743  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Prof. Dr. Dr.  Yasser  Sakr 
    • Am Klinikum1
    • 07747  Jena
    • Germany
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    • Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivmedizin
    • Mr.  Prof. Dr. Dr.  Yasser  Sakr 
    • Am Klinikum1
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft (DFG)
    • 53170  Bonn
    • Germany
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    • Instituto GRIFOLS S.A.
    • 08174  Barcelona
    • Spain
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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