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

Septic Shock Clinical Trial

— SQUEEZE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080038
• Other study ID #: 0833
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	CHU de Québec-Université Laval	Québec City	Quebec
Canada	Sickkids	Toronto	Ontario
Canada	Winnipeg Children's Hospital	Winnipeg	Manitoba

Sponsors (6)

Lead Sponsor	Collaborator
McMaster University	Canadian Blood Services, Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation, Pediatric Emergency Research Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   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