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NCT Number: NCT05453565

Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis

A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.

The investigators will include four multicentre, open-label, randomised, clinical trials:

  • Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942
  • Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236
  • Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028
  • Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499

All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.

The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants of the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials who had:

  • Suspected or proven infection
  • Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
  • Lactate ≥ 2.0 mmol/L
  • Requirement for vasopressors to meet perfusion targets

Exclusion criteria

Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS & EVIS trials

Treatment and study plan

Vasopressors

Other

A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets

Fluids

Other

A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required.

Primary outcomes

  1. All-cause mortality at 90 days post randomisation

    Time frame: 90 days

    Death from any cause at 90 days after randomisation

Secondary outcomes

  1. Time from randomisation to death

    Time frame: Up to day 90

    Time from randomisation to death

  2. Incidence of mechanical ventilation

    Time frame: from randomisation until day 90 post-randomisation

    Commencement of mechanical ventilation from randomisation until day 90 post-randomisation

  3. Incidence of acute renal replacement therapy

    Time frame: from randomisation until day 90 post-randomisation

    Commencement of renal replacement therapy from randomisation until day 90 post-randomisation

  4. Days alive free of organ support at 28 days post randomisation

    Time frame: from randomisation until day 28 post-randomisation

    days the patient is alive and receiving nil organ support from from randomisation until day 28 post-randomisation

  5. Duration of hospital stay

    Time frame: From randomisation until day 90 post-randomisation

    Length of time in hospital from randomisation until death or hospital discharge or day 90 post-randomisation

  6. Incidence of serious adverse events

    Time frame: from randomisation until day 90 post-randomisation

    Number of adverse events from randomisation until day 90 post-randomisation

  7. Duration of intensive care unit (ICU) stay

    Time frame: From randomisation until day 90 post-randomisation

    Length of time in ICU from randomisation until death or hospital discharge or day 90 post-randomisation

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Registry information

Official study title

Fluid Restricted Resuscitation in Sepsis With Hypotension Meta-Analysis (FRESHLY): Individual Patient Data Met-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS Trials

Acronym: FRESHLY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2022
Registry last updated
Jan 3, 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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