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Pilot Study for the SQUEEZE Trial

NCT01973907 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-08-18

No results posted yet for this study

Summary

The purpose of the SQUEEZE Trial is to determine which fluid resuscitation strategy results in the best outcomes for children treated for suspected or confirmed septic shock. In this study, eligible children will be randomized to either the 'Usual Care Arm' or the 'Fluid Sparing Arm'. Children will receive treatment according to current ACCM Septic Shock Resuscitation Guidelines, with the assigned resuscitation strategy used to guide administration of further fluid boluses as well as the timing of initiation and escalation of vasoactive medications to achieve ACCM recommended hemodynamic targets.

Conditions

  • Septic Shock

Interventions

OTHER

Fluid Sparing Resuscitation Strategy

Tier 1: Initiate IV/IO vasoactive medication infusion support immediately. Further IV/IO isotonic fluid bolus therapy \[crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)\] should be avoided; small volume isotonic fluid boluses \[5-10 mL/kg (250-500 mL for participants ≥ 50 kg)\] may be provided if required due to A. Clinically unacceptable delay in ability to initiate vasoactive medication infusion(s) and/or 2. Documented intravascular hypovolemia. Tier 2: Vasoactive medication(s) should be preferentially titrated/escalated to achieve recommended ACCM hemodynamic goals. Further IV/IO isotonic fluid bolus therapy \[crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)\] should be avoided; small volume isotonic fluid boluses \[5-10 mL/kg (250-500 mL for participants ≥ 50 kg)\] may be provided if required due to A. Documented intravascular hypovolemia. Intervention end: Patient is free from vasoactive medication support and shock is reversed.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Canadian Critical Care Trials Group

    collaborator OTHER

  • McMaster Children's Hospital

    lead OTHER

Principal Investigators

  • Melissa J Parker, MD, MSc · McMaster University and McMaster Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01973907 on ClinicalTrials.gov