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Protocol and Statistical Analysis Plan for the Vasopressin for Septic Shock Pragmatic (VASSPR) Cluster-Crossover
Ithan D Peltan1, Danielle Groat1, Jason R Jacobs1
1Department of Pulmonary and Critical Care Medicine (I. D. P., D. G., J. R. J., E. H. T., S. J. B., J. H. E., N. A., E. L. H., J. R. C., M. J. L., C. K., C. K. G., S. M. B., and L. M. L.), the Department of Pharmacy (S. C. and H. S.), the Department of Emergency Medicine (J. R. B. and T. D. M. T.), Intermountain Medical Center, Murray, the Division of Epidemiology (B. J. B.), Department of Medicine, University of Utah; the Division of Respiratory, Critical Care, and Occupational Pulmonary Medicine (E. L. H., C. K. G., and S. M. B.), Department of Medicine, University of Utah School of Medicine; Digital Technology Services (H. S., P. H., and T. D. M. T.), Intermountain Health, Salt Lake City; the Department of Emergency Medicine (A. T. S.), Park City Hospital, Park City, UT; the Division of Allergy, Pulmonary and Critical Care Medicine (M. W. S. and J. W. C.), Department of Medicine, and the Vanderbilt Institute for Clinical and Translational Research (M. W. S. and J. W. C.), Vanderbilt University Medical Center, Nashville, TN.
The Vasopressin for Septic Shock Pragmatic (VASSPR) trial investigates optimal vasopressin initiation thresholds for septic shock. This pragmatic trial aims to determine if a lower or higher threshold impacts 28-day mortality in critically ill patients.
Area of Science:
- Critical Care Medicine
- Pharmacology
- Clinical Trials
Background:
- Current guidelines recommend vasopressin as a preferred second-line agent for septic shock management.
- Optimal timing for vasopressin initiation remains an area of clinical uncertainty.
Purpose of the Study:
- To compare the efficacy of lower versus higher vasopressin initiation thresholds on 28-day mortality in septic shock patients.
- To evaluate the impact of different vasopressin initiation strategies on renal replacement therapy-free days.
Main Methods:
- The Vasopressin for Septic Shock Pragmatic (VASSPR) trial is a multicenter, cluster-randomized, pragmatic clinical trial.
- It compares initiating vasopressin at a lower threshold (0.1 mg/kg/min NEEs) versus a higher threshold (0.4 mg/kg/min NEEs).
- The primary outcome is 28-day all-cause mortality, with renal replacement therapy-free days as a key secondary outcome.
Main Results:
- This article details the protocol and statistical analysis plan for the VASSPR trial.
- Results regarding the primary and secondary outcomes are pending completion of the trial.
Conclusions:
- The VASSPR trial is designed to provide crucial data for optimizing vasopressor management in septic shock.
- Rigorous trial conduct and pre-specified statistical analysis are essential for reliable findings.
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