Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Sepsis
Shock
Septic Shock
Fluid Therapy
Resuscitation
Pediatrics
Emergency Medicine
Critical Care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Pediatric Emergency Research Canada
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Blood Services
name: Hamilton Health Sciences Corporation
First posted: 2017-03-15
Enrollment: 406
Sex: ALL
Minimum age (years): 29
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in time to shock reversal
timeFrame: This outcome can be ascertained typically within 14 days of randomization
Secondary outcomes:
measure: Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score
timeFrame: 28 days
measure: Measures of Organ Dysfunction - Acute Kidney Injury
timeFrame: 28 days
measure: Measures of Organ Dysfunction - Ventilator Free Days
timeFrame: 28 days
measure: Complications possibly attributable to fluid overload or third spacing of fluids - Soft tissue edema
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Complications possibly attributable to fluid overload or third spacing of fluids - Pulmonary edema
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Complications possibly attributable to fluid overload or third spacing of fluids - Pleural effusion requiring drainage
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Complications possibly attributable to fluid overload or third spacing of fluids - Abdominal Compartment Syndrome
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure
timeFrame: From randomization until 7 days after shock is reversed
measure: Complications possibly attributable to inotrope/vasopressor use - Clinical signs of digital tissue schema
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation
timeFrame: 90 days
measure: Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion
timeFrame: From randomization until 7 days after shock is reversed
measure: Critical Care Treatments as binary measurement yes/no
timeFrame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
measure: Paediatric Intensive Care Unit Length of Stay
timeFrame: Up to 90 days
measure: Hospital Length of Stay
timeFrame: Up to 90 days
measure: Mortality Measures
timeFrame: 28-, 90- day, hospital mortality
measure: Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Children's Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Toronto
country: Canada
facility: Sickkids
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Québec City
country: Canada
facility: CHU de Québec-Université Laval
state: Quebec
Study officials:
affiliation: McMaster Children's Hospital and McMaster University
name: Melissa Parker, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker MJ, Thabane L, Fox-Robichaud A, Liaw P, Choong K; Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group. A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial. Trials. 2016 Nov 22;17(1):556. doi: 10.1186/s13063-016-1689-2.
citation: Parker MJ. What Goes Up, Must Go Down? Pediatr Crit Care Med. 2018 Jun;19(6):579-581. doi: 10.1097/PCC.0000000000001543. No abstract available.