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
Bibliographic record
Abstract
OBJECTIVE: The overall objective of our research is to determine in children with septic shock whether the use of a fluid-sparing strategy results in improved clinical outcomes without an increased risk of adverse events compared to usual care. The specific objective of this pilot randomized controlled trial was to evaluate the feasibility of a definitive multicenter trial to answer our research question. DESIGN: Pragmatic, 2-arm, parallel group, open-label, prospective pilot randomized controlled trial including a nested biosample-based translational study. SETTING: Pediatric tertiary care center. PATIENTS: Children aged 29 days to <18 years of age presenting to the emergency department or admitted to an inpatient ward (including the PICU) with suspected or confirmed septic shock and a need for ongoing resuscitation. INTERVENTIONS: Fluid-sparing vs. usual care resuscitation strategy continued until shock reversal. The fluid-sparing intervention comprised instructions to restrict fluid bolus therapy in conjunction with early initiation and/or preferential use of vasoactive medication support as a strategy to spare fluid while targeting the hemodynamic goals specified in the American College of Critical Care Medicine Surviving Sepsis Guidelines. The usual care strategy did not limit the use of fluid bolus therapy. MEASUREMENTS AND MAIN RESULTS: Fifty-three were randomized to usual care (n = 27) or fluid-sparing (n = 26). Fifty-one participants were available for primary outcome analysis. Primary feasibility outcomes related to participant enrollment and protocol adherence. Enrollment rate was 1.8 (51/29); 95% confidence interval [CI]: 1.3-2.3 participants/month. Study procedures were implemented in 49/51 (96.1%), 95% CI: 86.5-99.5% participants within 1 h of randomization in a median (interquartile range [IQR]) of 8 (5, 15) minutes. The protocol required the use of an exception to consent process and consent for ongoing participation was 48/51 (94.1%), 95% CI: 83.8-98.8%. There were no serious adverse events. CONCLUSIONS: We concluded the large multicenter SQUEEZE trial feasible to conduct. TRIAL REGISTRATION: ClinicalTrials.gov [NCT01973907]. Registered October 27, 2013, https://clinicaltrials.gov/study/NCT01973907 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".