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

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Other: Fluid Sparing Resuscitation Strategy

• Registration Number: NCT03080038
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-28
• Study Start: 2017-03-06
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-15
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluid Sparing Resuscitation Strategy	Fluid Sparing Resuscitation Strategy	The treating physician and medical team are advised to follow the assigned Fluid Sparing Resuscitation Strategy to guide decisions regarding the IV/IO administration of further isotonic fluid boluses, and the timing of initiation and escalation of vasoactive medication infusions to target the therapeutic endpoints recommended in the ACCM guidelines for the resuscitation of neonatal and pediatric septic shock.

Primary Outcome Measures

Name	Time	Method
Difference in time to shock reversal	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 Outcome Measures

Name	Time	Method
Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score	28 days	Pediatric logistic organ dysfunction score
Measures of Organ Dysfunction - Acute Kidney Injury	28 days	Acute Kidney Injury
Measures of Organ Dysfunction - Ventilator Free Days	28 days	Ventilator Free Days
Complications possibly attributable to fluid overload or third spacing of fluids - Soft tissue edema	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Soft tissue edema
Complications possibly attributable to fluid overload or third spacing of fluids - Pulmonary edema	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Pulmonary edema
Complications possibly attributable to fluid overload or third spacing of fluids - Pleural effusion requiring drainage	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Pleural effusion requiring drainage
Complications possibly attributable to fluid overload or third spacing of fluids - Abdominal Compartment Syndrome	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Abdominal Compartment Syndrome
Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure	From randomization until 7 days after shock is reversed	Diuretic Exposure
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of digital tissue schema	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Clinical signs of digital tissue schema
Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation	90 days	Digital ischemia requiring revision amputation
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion	From randomization until 7 days after shock is reversed	Clinical signs of compromised bowel perfusion
Critical Care Treatments as binary measurement yes/no	Intervention Period (from randomization until shock is reversed; typically within 14 days)	Critical care treatments performed during intervention period.
Paediatric Intensive Care Unit Length of Stay	Up to 90 days	Paediatric Intensive Care Unit Length of Stay
Hospital Length of Stay	Up to 90 days	Hospital Length of Stay
Mortality Measures	28-, 90- day, hospital mortality	Death
Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate	28 days	Paediatric Intensive Care Unit Admission Rate

Trial Locations

Locations (8)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Children's Hospital of Western Ontario; 🇨🇦 London, Ontario, Canada

Sickkids; 🇨🇦 Toronto, Ontario, Canada

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada

CHU de Québec-Université Laval; 🇨🇦 Québec City, Quebec, Canada

Winnipeg Children's Hospital; 🇨🇦 Winnipeg, Manitoba, Canada