Septic ShockSQUEEZENCT03080038
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
A study testing Fluid Sparing Resuscitation Strategy in people with Septic Shock, run by McMaster University at 8 sites in Canada.
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'. Read more about this study
- Who is it for?
- Ages 29 days to 17 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fluid Sparing Resuscitation Strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 8 sitesCanada
- Study dates
- 6 Mar 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2C8
McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1
Children's Hospital of Western Ontario
London, Ontario, N6A 5W9
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
Sickkids
Toronto, Ontario, M5G 1X8
Winnipeg Children's Hospital
Winnipeg, Manitoba, R3A 1S9
About this study
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.
Read the detailed description
Please see published pilot trial protocol for more information about the SQUEEZE Trial and rationale for this study.
- Conditions
- Septic Shock
- Being tested
- Fluid Sparing Resuscitation Strategy
- Keywords
- Sepsis, Shock, Septic Shock, Fluid Therapy, Resuscitation, Pediatrics, Emergency Medicine, Critical Care
- Medical subject headings
- Shock, Septic, Sepsis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid Sparing Resuscitation StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Resuscitation Strategy | No intervention | Decisions regarding the IV/IO administration of isotonic fluid boluses and/or the initiation and escalation of vasoactive medication infusions are left to the discretion of the treating physician and medical team. We ask that vasoactive medications not be initiated until at least 60 mL/kg (3 litres for children ≥ 50 kg) of isotonic fluid bolus therapy has been administered. The treating physician and medical team are advised to follow ACCM guidelines for the resuscitation of neonatal and pediatric septic shock and to target ACCM recommended therapeutic endpoints. |
| Fluid Sparing Resuscitation Strategy | Experimental | 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. Receives: Other: Fluid Sparing Resuscitation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This outcome can be ascertained typically within 14 days of randomization
Secondary outcomes (16)
Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score
Pediatric logistic organ dysfunction score
Measured: 28 days
Measures of Organ Dysfunction - Acute Kidney Injury
Acute Kidney Injury
Measured: 28 days
Measures of Organ Dysfunction - Ventilator Free Days
Ventilator Free Days
Measured: 28 days
Complications possibly attributable to fluid overload or third spacing of fluids - Soft tissue edema
Soft tissue edema
Measured: 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
Pulmonary edema
Measured: 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
Pleural effusion requiring drainage
Measured: 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
Abdominal Compartment Syndrome
Measured: 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
Diuretic Exposure
Measured: From randomization until 7 days after shock is reversed
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of digital tissue schema
Clinical signs of digital tissue schema
Measured: Intervention Period (from randomization until shock is reversed; typically within 14 days)
Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation
Digital ischemia requiring revision amputation
Measured: 90 days
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion
Clinical signs of compromised bowel perfusion
Measured: From randomization until 7 days after shock is reversed
Critical Care Treatments as binary measurement yes/no
Critical care treatments performed during intervention period.
Measured: Intervention Period (from randomization until shock is reversed; typically within 14 days)
Paediatric Intensive Care Unit Length of Stay
Paediatric Intensive Care Unit Length of Stay
Measured: Up to 90 days
Hospital Length of Stay
Hospital Length of Stay
Measured: Up to 90 days
Mortality Measures
Death
Measured: 28-, 90- day, hospital mortality
Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate
Paediatric Intensive Care Unit Admission Rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start6 Mar 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Pediatric Emergency Research Canada, Canadian Institutes of Health Research (CIHR), Canadian Blood Services, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Melissa Parker, McMaster University
- Investigators
- Melissa Parker, MD, MSc, Principal investigator, McMaster Children's Hospital and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080038
- Sponsor's protocol ID
- 0833
- Acronym
- SQUEEZE
- Status last verified
- May 2022
- First submitted
- 28 Feb 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final trial data set will be made public.
Publications
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.
PubMed 27876084Parker MJ, Foster G, Fox-Robichaud A, Choong K, Mbuagbaw L, Thabane L; With the SQUEEZE Trial Steering Committee and on behalf of the SQUEEZE Trial Investigators, the Canadian Critical Care Trials Group, Pediatric Emergency Research Canada, and the Canadian Critical Care Translational Biology Group. Statistical analysis plan for the 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 (SQUEEZE). Crit Care Resusc. 2024 Jun 22;26(2):123-134. doi: 10.1016/j.ccrj.2024.02.002. eCollection 2024 Jun.
PubMed 39072232Parker 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.
PubMed 29863640
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03080038
- Acronym / sponsor ID
- SQUEEZE / 0833
- Conditions
- Septic Shock
- Keywords
- Sepsis, Shock, Septic Shock, Fluid Therapy, Resuscitation, Pediatrics, Emergency Medicine, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Pediatric Emergency Research Canada, Canadian Institutes of Health Research (CIHR), Canadian Blood Services, Hamilton Health Sciences Corporation
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Resuscitation Strategy | No intervention | –Decisions regarding the IV/IO administration of isotonic fluid boluses and/or the initiation and escalation of vasoactive medication infusions are left to the discretion of the treating physician and medical team. We ask that vasoactive medications not be initiated until at least 60 mL/kg (3 litres for children ≥ 50 kg) of isotonic fluid bolus therapy has been administered. The treating physician and medical team are advised to follow ACCM guidelines for the resuscitation of neonatal and pediatric septic shock and to target ACCM recommended therapeutic endpoints. |
| Fluid Sparing Resuscitation Strategy | Experimental | Other: Fluid Sparing Resuscitation StrategyThe 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. |
Who may qualify
- Ages
- 29 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid Sparing Resuscitation StrategyTier 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. | Other | Fluid Sparing Resuscitation Strategy |
Primary outcome
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.
16 secondary outcomes
Measures of Organ Dysfunction - Pediatric logistic organ dysfunction score
Time frame: 28 days
Measures of Organ Dysfunction - Acute Kidney Injury
Time frame: 28 days
Measures of Organ Dysfunction - Ventilator Free Days
Time frame: 28 days
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)
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)
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)
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)
Complications possibly attributable to fluid overload or third spacing of fluids - Diuretic Exposure
Time frame: From randomization until 7 days after shock is reversed
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)
Complications possibly attributable to inotrope/vasopressor use - Digital ischemia requiring revision amputation
Time frame: 90 days
Complications possibly attributable to inotrope/vasopressor use - Clinical signs of compromised bowel perfusion
Time frame: From randomization until 7 days after shock is reversed
Critical Care Treatments as binary measurement yes/no
Time frame: Intervention Period (from randomization until shock is reversed; typically within 14 days)
Paediatric Intensive Care Unit Length of Stay
Time frame: Up to 90 days
Hospital Length of Stay
Time frame: Up to 90 days
Mortality Measures
Time frame: 28-, 90- day, hospital mortality
Health Service Outcomes - Paediatric Intensive Care Unit Admission Rate
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 27876084Parker 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.
- Derived from this study: PubMed 39072232Parker MJ, Foster G, Fox-Robichaud A, Choong K, Mbuagbaw L, Thabane L; With the SQUEEZE Trial Steering Committee and on behalf of the SQUEEZE Trial Investigators, the Canadian Critical Care Trials Group, Pediatric Emergency Research Canada, and the Canadian Critical Care Translational Biology Group. Statistical analysis plan for the 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 (SQUEEZE). Crit Care Resusc. 2024 Jun 22;26(2):123-134. doi: 10.1016/j.ccrj.2024.02.002. eCollection 2024 Jun.
- Derived from this study: PubMed 29863640Parker 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.
- 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 trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The final trial data set will be made public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Parker, MD, MSc principal investigator
McMaster Children's Hospital and McMaster University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid Sparing Resuscitation Strategy in people with Septic Shock, run by McMaster University at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in time to shock reversal (time frame: This outcome can be ascertained typically within 14 days of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080038, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.