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

McMaster University8 sites in 1 country406 target enrollmentMarch 6, 2017

ConditionsSeptic Shock

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Septic Shock
Sponsor: McMaster University
Enrollment: 406
Locations: 8
Primary Endpoint: Difference in time to shock reversal
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 6, 2017

End Date

December 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McMaster University

Responsible Party

Principal Investigator

Melissa Parker

Associate Professor of Pediatrics, McMaster University; Staff Physician, McMaster Children's Hospital

McMaster University

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

Outcomes

Primary Outcomes

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

Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score(28 days)
Measures of Organ Dysfunction - Acute Kidney Injury(28 days)
Measures of Organ Dysfunction - Ventilator Free Days(28 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))
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))
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))
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))
Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure(From randomization until 7 days after shock is reversed)
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))
Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation(90 days)
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion(From randomization until 7 days after shock is reversed)
Critical Care Treatments as binary measurement yes/no(Intervention Period (from randomization until shock is reversed; typically within 14 days))
Paediatric Intensive Care Unit Length of Stay(Up to 90 days)
Hospital Length of Stay(Up to 90 days)
Mortality Measures(28-, 90- day, hospital mortality)
Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate(28 days)