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Not yet recruiting NCT05453565

Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis

— Observational Septic Shock Fluid Resuscitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vasopressors, Fluids.
Who it may be relevant to
Registry conditions: Septic Shock, Fluid Resuscitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Detailed description

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.

Interventions

  • Other Vasopressors
    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
  • Other Fluids
    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 outcome measures

  • All-cause mortality at 90 days post randomisation [Time frame: 90 days]
Secondary outcome measures (7)
  • Time from randomisation to death [Time frame: Up to day 90]
  • Incidence of mechanical ventilation [Time frame: from randomisation until day 90 post-randomisation]
  • Incidence of acute renal replacement therapy [Time frame: from randomisation until day 90 post-randomisation]
  • Days alive free of organ support at 28 days post randomisation [Time frame: from randomisation until day 28 post-randomisation]
  • Duration of hospital stay [Time frame: From randomisation until day 90 post-randomisation]
  • Incidence of serious adverse events [Time frame: from randomisation until day 90 post-randomisation]
  • Duration of intensive care unit (ICU) stay [Time frame: From randomisation until day 90 post-randomisation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05453565 · FRESHLY V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗