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Completed

NCT Number: NCT03654001

ALBumin Italian Outcome Septic Shock-BALANCED Trial (ALBIOSS-BALANCED)

Septic shock is a devastating condition often observed in ICU. It is characterized by pro-inflammatory and immune responses, organ failures, high incidence of AKI and lethality. Fluid resuscitation is pivotal as supportive therapy. At present, there are no effective therapies to improve survival of such clinical condition, often characterized by a mortality as high as 40% during the first 90 days from diagnosis.

This project proposes a large 2-by-2 factorial randomized clinical trial testing the efficacy of albumin and the low- chloride balanced crystalloid solutions (either Ringer Lactate, Ringer Acetate, or Crystalsol - BAL) in septic shock.

The investigators have recently concluded a multicenter, randomized trial, the ALBIOS trial, in which, in a post-hoc analysis, albumin, in addition to crystalloids, reduced 90-day mortality in patients with septic shock, as compared to crystalloids alone (Caironi P et al, 2014). Crystalloids with supra-physiological chloride content may deteriorate renal perfusion, increasing the risk of acute kidney injury (AKI) and mortality.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedali Riuniti di Ancona, Ancona, AN, Italy

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About this study

The project will consist of a 2-by-2 factorial, investigator-initiated, open-label, multicenter, randomized, controlled trial, with PROBE design (Prospective Randomized Open Trial with Blinded Evaluation of Outcomes), in patients with septic shock, as defined according to clinical criteria.

Patients will be randomized in a 1:1:1:1 ratio to one of the 4 study groups (Albumin + BAL, Albumin + NS, BAL, NS).

Both the primary endpoints will include events evaluated objectively: 90-day mortality and incidence of AKI, as assessed by KDIGO criteria (KDIGO Acute Kidney Injury Work Group, 2012).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with septic shock if they meet the two following criteria:

  • Presence of an infection (known or suspected) in at least one site:
  • Lung
  • Abdomen
  • Urinary tract
  • Others (blood, skin and soft tissues, central nervous system, bones and joints, cardiac system, reproductive organs).
  • Presence of a severe and acute, sepsis-related cardiovascular failure (as assessed by the SOFA score - see Annex 1), requiring vasopressor to maintain mean arterial pressure >=65 mmHg, despite adequate volume resuscitation a) Cardiovascular SOFA score > 2 (3 or 4) If the patient is unable to provide informed consent, she/he can be included in the trial provided that the requirements of ongoing laws are fulfilled; details on this approach are provided in the protocol, par 11.1 and related Annex 3. The patient will be informed about having been included in a clinical trial, as soon as she/he will regain consciousness.

Exclusion criteria

  • Age < 18 years
  • Moribund state
  • Known or suspected adverse reaction to albumin administration
  • Septic shock in patients with traumatic brain injury or a clinically active cerebral lesion (known or suspected)
  • Severe congestive heart failure (NYHA III and IV classes)
  • Clinical situations in which the use of albumin is known or supposed to be clinically beneficial (hepatic cirrhosis with ascites, malabsorption syndrome or protein-losing enteropathy, nephrotic syndrome, burns)
  • More than 24 hours after the onset of septic shock
  • Religious objection to the administration of human blood products
  • Presence of chronic end-stage renal disease
  • Severe hyperkalemia (> 6 mmol/L)
  • Known or suspected pregnancy based on patient information
  • Enrollment in other experimental interventional studies
  • Laboratory confirmation for SARS-CoV-2 infection

Treatment and study plan

Albumin

Biological

Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination.

Balanced

Other

Balanced crystalloid solutions are traditionally crystalloid solutions containing a relatively low concentration of chloride as compared to 0.9% NaCl containing solutions (Normal Saline).

Other names: Ringer Lactate, Ringer Acetate, Crystalsol

Primary outcomes

  1. All-cause 90-day mortality

    Time frame: Up to 90 days

    All-cause death from randomization to 90 days

  2. Combined co-primary endpoint

    Time frame: Up to 90 days

    The composite of all-cause death from randomization to 90 days and new occurrence of acute kidney injury (AKI).

Secondary outcomes

  1. ICU mortality

    Time frame: Up to ICU discharge, a median of 9 days

    All-cause death occurring in Intensive Care Unit (ICU)

  2. In-hospital mortality

    Time frame: Up to hospital discharge, a median of 20 days

    All-cause death occurring during hospital stay

  3. 1-year mortality

    Time frame: Up to 1 year

    All-cause death from randomization to 1 year

  4. SOFA score

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Severity and incidence of organ failures, as assessed by the Sequential Organ Failure Assessment (SOFA) score. SOFA score is used to determine the extent of organ function in a patient while in the intensive care unit. The score is based on 6 different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The scale of each score ranges from 0 (no dysfunction) to 4 (maximal dysfunction). The 6 scores are then added up to provide a global score: the highest the value, the worst the condition of the patient.

  5. Incidence of AKI during ICU stay

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Assessed by the Kidney Disease Improving Global Outcome (KDIGO) criteria as any of the following: (1) increase in serum creatinine >=0.3 mg/dl (26.5 mmol/l) within 48 hours; or (2) increase in SCr to >=1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine volume <0.5 ml/kg/h for 6 hours.

  6. RRT

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    First use of Renal Replacement Therapy (RRT) during ICU stay

  7. Need for vasopressors

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Duration of the need for vasopressors during ICU stay

  8. Mechanical ventilation

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Duration of mechanical ventilation during ICU stay

  9. Secondary infections in ICU

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Incidence of secondary-acquired infections during ICU stay

  10. Duration of stay in ICU

    Time frame: Up to ICU discharge, a median of 9 days

    Duration expressed as number of days spent in ICU

  11. Duration of stay in hospital

    Time frame: Up to hospital discharge, a median of 20 days

    Duration expressed as number of days spent in hospital

  12. 1-year functional and physical disability

    Time frame: Up to 1 year

    Evaluation by specific psyco-functional tests

Other outcomes

  1. Severe metabolic acidosis

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Incidence of severe metabolic acidosis

  2. Severe hyperkalemia

    Time frame: Up to 90 days or ICU discharge - a median of 9 days - whichever comes first

    Incidence of severe hyperkalemia

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

Registry information

Official study title

Efficacy of Albumin Replacement and Balanced Solution in Patients With Septic Shock (the ALBIOSS-BALANCED Trial): a 2-by-2 Factorial, Investigator-initiated, Open- Label, Multicenter, Randomized, Controlled Trial

Acronym: ALBIOSS-BAL

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 31, 2018
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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