Table 2 Detailed description of the SQUEEZE study arms
Intervention tier | Usual Care arm | Fluid Sparing arm |
|---|---|---|
Tier 1 | Usual Care | Early initiation of vasoactive medications to spare fluid |
Bolus fluid therapya,b | • Following randomization, further isotonic fluid bolus therapy [crystalloid (0.9% normal saline or Ringer’s lactate) or colloid (5% albumin)] may be administered in any volume and as requested by the caring physician | • Following randomization, further isotonic fluid bolus therapy [crystalloid (0.9% normal saline or Ringer’s lactate) or colloid (5% albumin)] should be avoided and provided only if required due to: 1. delay in the ability to immediately initiate vasoactive medication(s) and/or 2. to treat intravascular hypovolemia. The reason/indication for administration of further fluid bolus therapy prior to the initiation of vasoactive medications must be documented |
Vasoactive medicationc | • The decision to initiate vasoactive medication(s) is at the discretion of the treating physician. Vasoactive support should not be started until the participant has received a minimum of 60 mL/kg (3 L for participants ≥50 kg) of isotonic fluid as boluses (includes fluid boluses received in the 6 h prior to randomization) • The choice of initial vasoactive medication and the initial dose is to be at the discretion of the caring physician | • Vasoactive medication(s) should be initiated immediately following randomization • The choice of initial vasoactive medication and the initial dose is to be at the discretion of the caring physician |
Tier 2 | Usual Care | Preferential escalation of vasoactive medications |
Bolus fluid therapya,b | • Further isotonic fluid bolus therapy may be administered at the discretion of the caring physician • The type and dose of any further isotonic fluid bolus therapy is at the discretion of the caring physician | • Further isotonic fluid bolus therapy may be administered by the caring physician to treat documented inadequate intravascular filling/preload • If further isotonic fluid bolus therapy is provided, the dose provided should be in 5–10-mL/kg aliquots (250-500 mL for participants ≥50 kg) with the lowest acceptable volume preferred and the indication for administration documented • Aliquots of isotonic fluid bolus therapy may be administered “back-to-back” if required to address inadequate intravascular volume status • The type of isotonic fluid bolus therapy provided is at the discretion of the caring physician |
Vasoactive medicationc | • If initiated, vasoactive medication(s) may be titrated (increased, decreased, or discontinued) at the discretion of the caring physician • Additional vasoactive medication(s) may be initiated at the discretion of the caring physician | • Escalation of vasoactive medications should be the first line to achieve hemodynamic goals (provided intravascular volume status is judged to be adequate) • The initiated vasoactive medication(s) may be titrated (increased, decreased, or discontinued) at the discretion of the caring physician • Additional vasoactive medication(s) may be initiated at the discretion of the caring physician |
Intervention end | • When the patient is free from vasoactive medication support and shock is reversed or the patient is placed on mechanical circulatory support,e.g., extracorporeal membrane oxygenation (ECMO) or death occurs | • When the patient is free from vasoactive medication support and shock is reversed or the patient is placed on mechanical circulatory support, e.g., ECMO or death occurs |