Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis

NCT05453565 | Not Yet Recruiting

• 1 other identifier: FRESHLY V1
• Study Type: observational
• Target: 7,838
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Septic Shock; Fluid Resuscitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 90 days post randomisation

  Death from any cause at 90 days after randomisation

  90 days

Secondary Outcomes (7)

• Time from randomisation to death

  Up to day 90

• Incidence of mechanical ventilation

  from randomisation until day 90 post-randomisation

• Incidence of acute renal replacement therapy

  from randomisation until day 90 post-randomisation

• Days alive free of organ support at 28 days post randomisation

  from randomisation until day 28 post-randomisation

• Duration of hospital stay

  From randomisation until day 90 post-randomisation

Study Arms (2)

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: Vasopressors

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.

Other: Fluids

Interventions

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

Vasopressors

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.

Fluids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All trials include adult patients requiring resuscitation for hypotension or hypoperfusion due to suspected sepsis as defined in the original studies. Participants may be enrolled in the emergency department, acute care ward or intensive care unit.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Vasoconstrictor Agents; Fluid Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: July 12, 2022
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2025-01