Evidence map›Paper›PMID 39072232›Full record

ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2024

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).

Melissa J Parker, Gary Foster, Alison Fox-Robichaud, Karen Choong, Lawrence Mbuagbaw, Lehana Thabane, 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

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01973907 phase3completednot on this map

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)

TypeinterventionalSponsorMcMaster Children's HospitalRan2014 to 2016Enrolled53ConditionsSeptic ShockArmsFluid Sparing Resuscitation Strategy
NCT03080038 nacompletednot on this map

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

TypeinterventionalSponsorMcMaster UniversityRan2017 to 2021Enrolled406ConditionsSeptic ShockArmsFluid Sparing Resuscitation Strategy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Melissa J ParkerDivision of Pediatric Critical Care, Department of Pediatrics, McMaster Children's Hospital and McMaster University, 1280 Main St W. HSC 3E-20, Hamilton, L8S 4K1, Ontario, Canada.
Gary FosterBiostatistics Unit,/FSORC, St Joseph's Healthcare Hamilton, 3rd floor Martha Wing. 50 Charlton Avenue East, Hamilton, L8N 4A6, Canada.
Alison Fox-RobichaudDepartment of Medicine, McMaster University, DBRI, Rm C5-106 & 107, 237 Barton Street East, Hamilton, L8L 2X2, Ontario, Canada.
Karen ChoongDivision of Pediatric Critical Care, Department of Pediatrics, McMaster Children's Hospital and McMaster University, 1280 Main St W. HSC 3E-20, Hamilton, L8S 4K1, Ontario, Canada.
Lawrence MbuagbawDepartment of Health Research Methods, Evidence, and Impact, McMaster University, 1200 Main St W. Hamilton, L8N 3Z5, Ontario, Canada.
Lehana ThabaneDivision of Pediatric Critical Care, Department of Pediatrics, McMaster Children's Hospital and McMaster University, 1280 Main St W. HSC 3E-20, Hamilton, L8S 4K1, Ontario, Canada.
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

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The SQUEEZE trial is a multicentred randomized controlled trial which seeks to determine the optimal approach to fluid resuscitation in paediatric septic shock. SQUEEZE also includes a nested translational study, SQUEEZE-D, investigating the value of plasma cell-free DNA for prediction of clinical outcomes. Objective: To present a pre-specified statistical analysis plan (SAP) for the SQUEEZE trial prior to finalizing the trial data set and prior to commencing data analysis. Design: SQUEEZE is a pragmatic, two-arm, open-label, prospective multicentre randomized controlled trial. Setting: Canadian paediatric tertiary care centres. Participants: Paediatric patients with suspected sepsis and persistent signs of shock in need of ongoing resuscitation. Sample size target: 400 participants. Interventions: The trial is designed to compare a fluid-sparing resuscitation strategy to usual care. Main outcome measures: The primary outcome for the SQUEEZE trial is the time to shock reversal (in hours). The primary outcome analysis will assess the difference in time to shock reversal between the intervention and control groups, reported as point estimate with 95% confidence intervals. The statistical test for the primary analysis will be a two-sided t-test. Secondary outcome measures include clinical outcomes and adverse events including measures of organ dysfunction and mortality outcomes. Results: The SAP presented here is reflective of and where necessary clarifies in detail the analysis plan as presented in the trial protocol. The SAP includes a mock CONSORT diagram, figures and tables. Data collection methods are summarized, primary and secondary outcomes are defined, and outcome analyses are described. Conclusions: We have developed a statistical analysis plan for the SQUEEZE Trial for transparency and to align with best practices. Analysis of SQUEEZE Trial data will adhere to the SAP to reduce the risk of bias. Registration: ClinicalTrials.gov identifiers: Definitive trial NCT03080038; Registered Feb 28, 2017. Pilot Trial NCT01973907; Registered Oct 27, 2013.

Indexed as

Fluid therapyPaediatricsResuscitationSepsisShock

Identifiers

PMID39072232
PMCPMC11282343

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.