Title {1} | Senolytics To slOw Progression of Sepsis (STOP-Sepsis) in elderly patients: study protocol for a multicenter, randomized, adaptive allocation clinical trial |
Trial registration {2a and 2b}. | This trial is registered to clinicaltrials.gov under identifier NCT05758246, first posted on March 7, 2023. |
Protocol version {3} | Protocol version 2.0, dated February 9, 2024. |
Funding {4} | This trial is supported by the National Institute on Aging of the National Institutes of Health under award numbers U01AG076929 and R33AG61456 (Translational Geroscience Network). |
Author details {5a} |
Milena Silva*, Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN 55455. silva343@umn.edu David A. Wacker*, Division of pulmonary, allergy, critical care and sleep medicine, Department of medicine, University of Minnesota Medical School, Minneapolis, MN 55455. wack0012@umn.edu Brian E. Driver, Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, 55,415. brian.driver@hcmed.org Abbey Staugaitis, Department of Emergency Medicine, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN 55414. staug002@umn.edu Laura J. Niedernhofer, Institute on the Biology of Aging and Metabolism, Department of Biochemistry, Molecular Biology, and Biophysics, University of Minnesota, Minneapolis, MN 55455, lniedern@umn.edu Elizabeth L. Schmidt, Institute on the Biology of Aging and Metabolism, Department of Biochemistry, Molecular Biology, and Biophysics, University of Minnesota, Minneapolis, MN 55455, thom4573@umn.edu James L. Kirkland, Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cedars-Sinai Medical Center, West Hollywood, CA 90069, james.kirkland@cshs.org Tamara Tchkonia, Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cedars-Sinai Medical Center, West Hollywood, CA 90069, tamar.tchkonia@cshs.org Tamara Evans, Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cedars-Sinai Medical Center, West Hollywood, CA 90069, tamara.evans@cshs.org Carlos Hines Serrano, Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN 55455. serra072@umn.edu Steffen Ventz, Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN 55455. ventz001@umn.edu Joseph S. Koopmeiners, Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota, Minneapolis, MN 55455. koopm007@umn.edu Michael A. Puskarich, Department of Emergency Medicine, University of Minnesota School of Medicine, Minneapolis MN 55455. mike-em@umn.edu** The STOP-Sepsis Investigators *These authors contributed equally to this work **Corresponding author |
Name and contact information for the trial sponsor {5b} |
Michael A. Puskarich Department of Emergency Medicine University of Minnesota School of Medicine 717 Delaware St SE Suite 508 Minneapolis, MN 55455. mike-em@umn.edu |
Role of sponsor {5c} |
Dr. Puskarich is the investigator-sponsor for the study. He was directly involved in trial design, and will be involved with subject recruitment, data collection and interpretation, and manuscript preparation. He has ultimate oversight authority over all trial activities at all sites. The administrative and funding instrument used for this study is the cooperative agreement, an “assistance” mechanism in which substantial National Institute on Aging (NIA) programmatic involvement with the investigators is anticipated during the performance of the activities based on the terms and condition of the U01AG076929 award. The NIA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. The NIA must approve the study protocol and protocol changes. |