Septic ShockPhase 3SQUEEZENCT01973907
Pilot Study for the SQUEEZE Trial
A Phase 3 study testing Fluid Sparing Resuscitation Strategy in people with Septic Shock, run by McMaster Children's Hospital at 1 site 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
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 3
- 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.
- 1. Age 29 days to less than 18 years of age
- 2a) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)
- 2b) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)
- 2c) 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
- 3. 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
1 site in 1 country.
About this study
Official title: Pilot Study 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)
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
Current pediatric surviving sepsis guidelines from the American College of Critical Care Medicine (ACCM) emphasize an early and goal-directed approach to resuscitation. These guidelines suggest that fluid resuscitation should be aggressive with repeated intravenous (IV) fluid boluses of 20 mL/kg, such that some children may require as much as 200 mL/kg of fluid to achieve therapeutic endpoints. The guidelines also recommend the initiation of vasoactive agents at the stage of "fluid refractory shock", i.e. when there is persistent hypoperfusion despite at least 60 ml/kg IV fluid. Improvements in pediatric septic shock survival have been attributed to adherence to the first iteration of the ACCM septic shock guidelines, and the use of goal directed targets. However, the largest and most publicized pediatric trial of fluid resuscitation in children with suspected septic shock (FEAST Trial), published in NEJM in 2011, demonstrated an increased mortality among children treated with aggressive fluid resuscitation in comparison to the conservative fluid resuscitation arm. As a result, the pediatric critical care community clearly acknowledges that these results, while important, are not necessarily generalizable to developed countries such as Canada.
Emerging publications in the ICU literature suggest that excessive compared to conservative fluid administration in adults with septic shock worsens outcomes such as duration of mechanical ventilation, complications related to the third-spacing of fluids, length of ICU stay, and mortality. A systematic review published in August 2012 reveals a paucity of randomized controlled trial (RCT) evidence apart from the FEAST trial examining the impact of fluid resuscitation on mortality in children with septic shock. This raises the important question of whether children in developed countries would also benefit from a fluid sparing resuscitation strategy to achieve the ACCM goal-directed targets. Use of such a fluid sparing strategy would, by default, require earlier initiation and preferential escalation of vasoactive medications to meet ACCM hemodynamic goals. The optimal degree of fluid resuscitation and the timing of initiation of vasoactive support in order to achieve therapeutic targets in children with septic shock remains unanswered.
This Pilot Randomized Controlled Trial constitutes the first step in answering our research question of whether, in pediatric patients with septic shock, use of a fluid sparing strategy to achieve ACCM therapeutic goals, results in improved clinical outcomes without an increased risk of adverse events, compared to the usual care of aggressive fluid resuscitation as currently recommended by the ACCM guidelines. The purpose of the pilot study is to determine feasibility and inform the appropriate methodological design of the larger multi-centre RCT to fully answer our research question. The hypothesis of the pilot study is that the SQUEEZE Trial is feasible to conduct.
- Conditions
- Septic Shock
- Being tested
- Fluid Sparing Resuscitation Strategy
- Keywords
- Sepsis, Septic Shock, Fluid Therapy, Pediatrics, Resuscitation, Emergency Medicine, Critical Care
- Medical subject headings
- Shock, Septic, Sepsis
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.
Feasibility of conducting the SQUEEZE Trial
The Primary Outcome of Feasibility of conducting the SQUEEZE Trial will be evaluated based on the following:
- Participant enrolment rate: We will define success as an enrolment rate of at least 2 patients/month (recognizing that enrolment may be slower during the study run-in phase).
- Protocol adherence: the ability to execute the study procedures. We will assess our ability to initiate study procedures in enrolled patients within 1 hour of randomization.
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Secondary outcomes (5)
Appropriateness of eligibility criteria
We will determine our ability to enroll patients based on the current eligibility criteria, to inform the design of a future multi-centered RCT.
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Clinical outcomes
We will assess our ability to collect clinical outcome data of interest to determine the most appropriate outcomes, perform a sample size calculation, and inform the design of a definitive multi-centered RCT. Clinical outcomes include:
- PICU admission rate, PICU Length of Stay, Ventilator Free Days, Acuity Scores (PRISM III), Organ Dysfunction scores (PELOD, PELOD 2), Vasoactive Medication Score, Mortality (28-day, 60-day, and 90-day), Hospital Mortality ii) Adverse Events- complications which may be attributable to third spacing of fluid, or inotrope/vasopressor use, including: Intrabdominal Hypertension, Abdominal Compartment Syndrome, Pulmonary Edema, Pleural Effusion requiring drainage, Signs of Digital Ischemia, Digital/Limb Revision amputation, Bowel Ischemia iii) Short term hemodynamic outcomes- time to shock reversal determined by freedom from vasoactive medication(s), bedside hemodynamic measurements (HR, MAP, CVP, and non-invasive CO (CI) measurement (USCOM)
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Process Feasibility
We will collect descriptive data related to study Process feasibility to inform conduct of a multi-centred RCT
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Resource Feasibility
We will collect descriptive data related to study Resource feasibility to inform conduct of a multi-centred RCT.
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Management Feasibility
We will collect descriptive data related to study Management feasibility to inform conduct of a multi-centred RCT.
Measured: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University, Canadian Critical Care Trials Group
- Responsible party
- Principal investigator, Melissa J Parker, MD, MSc, McMaster Children's Hospital
- Investigators
- Melissa J Parker, MD, MSc, Principal investigator, McMaster University and McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973907
- Sponsor's protocol ID
- 13-295
- Acronym
- SQUEEZE
- Status last verified
- Aug 2016
- First submitted
- 27 Oct 2013
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The final trial data set will be made publicly available.
Publications
Parker MJ, Choong K, Fox-Robichaud A, Liaw PC, Thabane L; Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group. The SQUEEZE pilot 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. Pilot Feasibility Stud. 2025 Nov 28;11(1):153. doi: 10.1186/s40814-025-01731-4.
PubMed 41316443Parker 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, 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 27876084
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study 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)
- ClinicalTrials.gov ID
- NCT01973907
- Acronym / sponsor ID
- SQUEEZE / 13-295
- Conditions
- Septic Shock
- Keywords
- Sepsis, Septic Shock, Fluid Therapy, Pediatrics, Resuscitation, Emergency Medicine, Critical Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation, McMaster University, Canadian Critical Care Trials Group
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Nov 2013 (estimated)
- 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
Current pediatric surviving sepsis guidelines from the American College of Critical Care Medicine (ACCM) emphasize an early and goal-directed approach to resuscitation. These guidelines suggest that fluid resuscitation should be aggressive with repeated intravenous (IV) fluid boluses of 20 mL/kg, such that some children may require as much as 200 mL/kg of fluid to achieve therapeutic endpoints. The guidelines also recommend the initiation of vasoactive agents at the stage of "fluid refractory shock", i.e. when there is persistent hypoperfusion despite at least 60 ml/kg IV fluid. Improvements in pediatric septic shock survival have been attributed to adherence to the first iteration of the ACCM septic shock guidelines, and the use of goal directed targets. However, the largest and most publicized pediatric trial of fluid resuscitation in children with suspected septic shock (FEAST Trial), published in NEJM in 2011, demonstrated an increased mortality among children treated with aggressive fluid resuscitation in comparison to the conservative fluid resuscitation arm. As a result, the pediatric critical care community clearly acknowledges that these results, while important, are not necessarily generalizable to developed countries such as Canada.
Emerging publications in the ICU literature suggest that excessive compared to conservative fluid administration in adults with septic shock worsens outcomes such as duration of mechanical ventilation, complications related to the third-spacing of fluids, length of ICU stay, and mortality. A systematic review published in August 2012 reveals a paucity of randomized controlled trial (RCT) evidence apart from the FEAST trial examining the impact of fluid resuscitation on mortality in children with septic shock. This raises the important question of whether children in developed countries would also benefit from a fluid sparing resuscitation strategy to achieve the ACCM goal-directed targets. Use of such a fluid sparing strategy would, by default, require earlier initiation and preferential escalation of vasoactive medications to meet ACCM hemodynamic goals. The optimal degree of fluid resuscitation and the timing of initiation of vasoactive support in order to achieve therapeutic targets in children with septic shock remains unanswered.
This Pilot Randomized Controlled Trial constitutes the first step in answering our research question of whether, in pediatric patients with septic shock, use of a fluid sparing strategy to achieve ACCM therapeutic goals, results in improved clinical outcomes without an increased risk of adverse events, compared to the usual care of aggressive fluid resuscitation as currently recommended by the ACCM guidelines. The purpose of the pilot study is to determine feasibility and inform the appropriate methodological design of the larger multi-centre RCT to fully answer our research question. The hypothesis of the pilot study is that the SQUEEZE Trial is feasible to conduct.
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 (6 listed)
- Inclusion Criteria for 1 and 3 must be answered YES to be eligible for study.
- 1. Age 29 days to less than 18 years of age
- 2a) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output)
- 2b) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause)
- 2c) 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
Feasibility of conducting the SQUEEZE Trial
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
The Primary Outcome of Feasibility of conducting the SQUEEZE Trial will be evaluated based on the following: 1. Participant enrolment rate: We will define success as an enrolment rate of at least 2 patients/month (recognizing that enrolment may be slower during the study run-in phase). 2. Protocol adherence: the ability to execute the study procedures. We will assess our ability to initiate study procedures in enrolled patients within 1 hour of randomization.
5 secondary outcomes
Appropriateness of eligibility criteria
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Clinical outcomes
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Process Feasibility
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Resource Feasibility
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
Management Feasibility
Time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment
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 18 Aug 2016.
- Derived from this study: PubMed 41316443Parker MJ, Choong K, Fox-Robichaud A, Liaw PC, Thabane L; Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group. The SQUEEZE pilot 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. Pilot Feasibility Stud. 2025 Nov 28;11(1):153. doi: 10.1186/s40814-025-01731-4.
- 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 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.
- Individual participant dataSharing planned: Yes. The final trial data set will be made publicly available.
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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 J Parker, MD, MSc principal investigator
McMaster University and McMaster Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluid Sparing Resuscitation Strategy in people with Septic Shock, run by McMaster Children's Hospital at 1 site 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 6 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of conducting the SQUEEZE Trial (time frame: The earliest of: 1. Recruitment of the planned 50 participants, or 2. 24 months following initiation of recruitment). 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 NCT01973907, 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 18 Aug 2016.