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Septic ShockPhase 3ALBIOSS-BALNCT03654001

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

A Phase 3 study testing Albumin and Balanced in people with Septic Shock, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 37 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Septic Shock
What is being tested?
Albumin and Balanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,319 participants
Where
37 sitesItaly
Study dates
7 May 2019to 31 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

Italy37 sites

  • Ospedale SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Ospedali Riuniti di Ancona

    Ancona, AN, 60126

  • AOU Policlinico di Bari

    Bari, BA, 70124

  • ASST Papa Giovanni XXIII

    Bergamo, BG, 24127

  • Policlinico Sant'Orsola-Malpighi

    Bologna, BO, 40138

  • Ospedale del Mugello

    Borgo San Lorenzo, FI, 50032

  • ASST Nord Milano - Ospedale Bassini

    Cinisello Balsamo, MI, 20092

  • Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna

    Cona, FE, 44124

  • Presidio Ospedaliero di Desio

    Desio, MB, 20039

  • Ospedale San Giuseppe

    Empoli, FI, 50053

  • AOU Careggi

    Florence, FI, 50134

  • ASST Ovest Milano

    Legnano, MI, 20025

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, MI, 20122

  • ASST Fatebenefratelli - Sacco P.O. Sacco

    Milan, MI, 20157

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

  • Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena

    Modena, MO, 41125

  • Ospedale Santa Croce

    Moncalieri, TO, 10024

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, MB

  • Azienda Ospedaliero - Universitaria S. Luigi Gonzaga

    Orbassano, TO, 10043

  • Ospedale Colline dell'Albegna

    Orbetello, GR, 58045

  • AOU Policlinico Paolo Giaccone

    Palermo, PA, 90127

  • ISMETT

    Palermo, PA, 90127

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV, 27100

  • AOU Pisana

    Pisa, PI, 56126

  • As FO Azienda sanitaria Friuli Occidentale

    Pordenone, PN, 33170

  • IRCCS ASMN Reggio Emilia

    Reggio Emilia, RE, 43123

  • Ospedale Infermi di Rimini

    Rimini, Rimini, 47923

  • Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore

    Roma, RM, 00168

  • IRCCS Policlinico San Donato

    San Donato Milanese, MI, 20097

  • ASST BG Est - Ospedale Bolognini

    Seriate, BG, 24068

  • AOU Città della Salute e della Scienza di Torino

    Torino, TO, 10126

  • Ospedale Santa Chiara

    Trento, TN, 38122

  • AST BG Ovest - PO Treviglio

    Treviglio, BG, 24047

  • ASU Giuliano Isontina

    Trieste, TS, 34128

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, UD, 33100

  • Ospedale di Circolo e Fondazione Macchi

    Varese, VA, 21100

  • Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, VR, 37126

Other trials in Italy

About this study

Official 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

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.

Read the detailed description

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).

Conditions
Septic Shock
Being tested
Albumin, Balanced
Keywords
Septic Shock, Albumin, Balanced crystalloids
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlbuminBiological

    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.

  • BalancedOther

    Also called Ringer Lactate, Ringer Acetate, Crystalsol

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

Study groups in NCT03654001
Study groupRoleWhat they receive
Albumin + BalancedExperimentalHuman 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 crystalloid solutions According to the preference and the standard use of the participating center: * Ringer Lactate * Ringer Acetate * Crystalsol
Receives: Biological: Albumin; Other: Balanced
Albumin + SalineExperimentalHuman 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. Normal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).
Receives: Biological: Albumin
BalancedExperimentalBalanced crystalloid solutions (Ringer Lactate, Ringer Acetate, Crystalsol)
Receives: Other: Balanced
SalineNo interventionNormal Saline Na+ 154 mEq/L, Cl- 154 mEq/L (0.9% NaCl).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause 90-day mortality

    All-cause death from randomization to 90 days

    Measured: Up to 90 days

  2. Combined co-primary endpoint

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

    Measured: Up to 90 days

Secondary outcomes (12)

  1. ICU mortality

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

    Measured: Up to ICU discharge, a median of 9 days

  2. In-hospital mortality

    All-cause death occurring during hospital stay

    Measured: Up to hospital discharge, a median of 20 days

  3. 1-year mortality

    All-cause death from randomization to 1 year

    Measured: Up to 1 year

  4. SOFA score

    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.

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

  5. Incidence of AKI during ICU stay

    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.

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

  6. RRT

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

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

  7. Need for vasopressors

    Duration of the need for vasopressors during ICU stay

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

  8. Mechanical ventilation

    Duration of mechanical ventilation during ICU stay

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

  9. Secondary infections in ICU

    Incidence of secondary-acquired infections during ICU stay

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

  10. Duration of stay in ICU

    Duration expressed as number of days spent in ICU

    Measured: Up to ICU discharge, a median of 9 days

  11. Duration of stay in hospital

    Duration expressed as number of days spent in hospital

    Measured: Up to hospital discharge, a median of 20 days

  12. 1-year functional and physical disability

    Evaluation by specific psyco-functional tests

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start7 May 2019
  3. Primary completion31 Oct 2024
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2-by-2 factorial design, open-label, multicenter, randomized, controlled trial, 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 groups (Albumin + BAL, Albumin + NS, BAL, NS).
Masking
None (open label)
Enrolment
1,319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03654001
Sponsor's protocol ID
RF-2016-02361583
Acronym
ALBIOSS-BAL
Status last verified
Jan 2025
First submitted
3 Aug 2018
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caironi P, Tognoni G, Masson S, Fumagalli R, Pesenti A, Romero M, Fanizza C, Caspani L, Faenza S, Grasselli G, Iapichino G, Antonelli M, Parrini V, Fiore G, Latini R, Gattinoni L; ALBIOS Study Investigators. Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med. 2014 Apr 10;370(15):1412-21. doi: 10.1056/NEJMoa1305727. Epub 2014 Mar 18.

    PubMed 24635772

  • SAFE Study Investigators; Finfer S, McEvoy S, Bellomo R, McArthur C, Myburgh J, Norton R. Impact of albumin compared to saline on organ function and mortality of patients with severe sepsis. Intensive Care Med. 2011 Jan;37(1):86-96. doi: 10.1007/s00134-010-2039-6. Epub 2010 Oct 6.

    PubMed 20924555

  • Patel A, Laffan MA, Waheed U, Brett SJ. Randomised trials of human albumin for adults with sepsis: systematic review and meta-analysis with trial sequential analysis of all-cause mortality. BMJ. 2014 Jul 22;349:g4561. doi: 10.1136/bmj.g4561.

    PubMed 25099709

  • Semler MW, Self WH, Rice TW. Balanced Crystalloids versus Saline in Critically Ill Adults. N Engl J Med. 2018 May 17;378(20):1951. doi: 10.1056/NEJMc1804294.

    PubMed 29768150

  • Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

    PubMed 23984731

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Albumin and Balanced in people with Septic Shock, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 37 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause 90-day mortality (time frame: Up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654001, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.

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