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Completed

NCT Number: NCT03080038

SQUEEZE Trial: A Trial to Determine Whether Septic Shock Reversal is Quicker in Pediatric Patients Randomized to an Early Goal Directed Fluid Sparing Strategy vs. Usual Care

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.

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Key information

Age range

29 day–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

Please see published pilot trial protocol for more information about the SQUEEZE Trial and rationale for this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

for 1 and 3 must be answered YES to be eligible for study.

  • Age 29 days to less than 18 years of age
  • Patient has Persistent Signs of Shock including one or more of the following:
  • Vasoactive Medication Dependence
  • Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age)
  • Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)
  • Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)
  • Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 6 hours for patients weighing 50 kg or more.
  • Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c.

Exclusion criteria

  • Patient admitted to the Neonatal Intensive Care Unit (NICU)
  • Patient requiring resuscitation in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU)
  • Full active resuscitative treatment not within the goals of care
  • Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock)
  • Previous enrolment in this trial, where known by the research team

Treatment and study plan

Fluid Sparing Resuscitation Strategy

Other

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.

Primary outcomes

  1. Difference in time to shock reversal

    Time frame: This outcome can be ascertained typically within 14 days of randomization

    Difference (in hours) in time to shock reversal between the two study groups. Not available where death occurs while still in shock, or if the patient is placed on mechanical circulatory support for refractory shock.

Secondary outcomes

  1. Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score

    Time frame: 28 days

    Pediatric logistic organ dysfunction score

  2. Measures of Organ Dysfunction - Acute Kidney Injury

    Time frame: 28 days

    Acute Kidney Injury

  3. Measures of Organ Dysfunction - Ventilator Free Days

    Time frame: 28 days

    Ventilator Free Days

  4. Complications possibly attributable to fluid overload or third spacing of fluids - Soft tissue edema

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Soft tissue edema

  5. Complications possibly attributable to fluid overload or third spacing of fluids - Pulmonary edema

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Pulmonary edema

  6. Complications possibly attributable to fluid overload or third spacing of fluids - Pleural effusion requiring drainage

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Pleural effusion requiring drainage

  7. Complications possibly attributable to fluid overload or third spacing of fluids - Abdominal Compartment Syndrome

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Abdominal Compartment Syndrome

  8. Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure

    Time frame: From randomization until 7 days after shock is reversed

    Diuretic Exposure

  9. Complications possibly attributable to inotrope/vasopressor use - Clinical signs of digital tissue schema

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Clinical signs of digital tissue schema

  10. Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation

    Time frame: 90 days

    Digital ischemia requiring revision amputation

  11. Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion

    Time frame: From randomization until 7 days after shock is reversed

    Clinical signs of compromised bowel perfusion

  12. Critical Care Treatments as binary measurement yes/no

    Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)

    Critical care treatments performed during intervention period.

  13. Paediatric Intensive Care Unit Length of Stay

    Time frame: Up to 90 days

    Paediatric Intensive Care Unit Length of Stay

  14. Hospital Length of Stay

    Time frame: Up to 90 days

    Hospital Length of Stay

  15. Mortality Measures

    Time frame: 28-, 90- day, hospital mortality

    Death

  16. Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate

    Time frame: 28 days

    Paediatric Intensive Care Unit Admission Rate

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Blood Services
  • Canadian Critical Care Trials Group
  • Canadian Institutes of Health Research (CIHR)
  • Hamilton Health Sciences Corporation
  • Pediatric Emergency Research Canada

Registry information

Acronym: SQUEEZE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2017
Registry last updated
May 9, 2022

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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