Articles: sepsis.
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Journal of critical care · Feb 2024
Randomized Controlled Trial Multicenter StudyThe safety and efficacy of stem cells for the treatment of severe community-acquired bacterial pneumonia: A randomized clinical trial.
Evaluate the safety profile of expanded allogeneic adipose-derived mesenchymal stem cell (eASC) for the treatment of severe community-acquired bacterial pneumonia (CABP). ⋯ Cx611 was well tolerated in severe CABP. These data provide insights for future stem cell clinical study designs, endpoints and sample size calculation.
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Critical care medicine · Feb 2024
Randomized Controlled TrialEffect of Automated Real-Time Feedback on Early-Sepsis Care: A Pragmatic Clinical Trial.
To determine if a real-time monitoring system with automated clinician alerts improves 3-hour sepsis bundle adherence. ⋯ Real-time monitoring and paging alerts significantly increased orders for and delivery of guideline-adherent care for suspected sepsis patients at risk of 3-hour bundle nonadherence. The trial was underpowered to determine whether adherence affected mortality. Despite enrolling patients with clinically suspected sepsis, early antibiotic discontinuation and pan-culture negativity were common, highlighting challenges in identifying appropriate patients for sepsis bundle application.
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Intensive care medicine · Jan 2024
Randomized Controlled TrialPhase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL).
Ilofotase alfa is a human recombinant alkaline phosphatase with reno-protective effects that showed improved survival and reduced Major Adverse Kidney Events by 90 days (MAKE90) in sepsis-associated acute kidney injury (SA-AKI) patients. REVIVAL, was a phase-3 trial conducted to confirm its efficacy and safety. ⋯ Among critically ill patients with SA-AKI, ilofotase alfa did not improve day 28 survival. There may, however, be reduced MAKE90 events. No safety concerns were identified.
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Am. J. Respir. Crit. Care Med. · Dec 2023
Randomized Controlled Trial Multicenter StudyEarly Video Assisted Thoracoscopic Surgery (VATS) or Intrapleural Enzyme Therapy (IET) in Pleural Infection - A Feasibility Randomized Controlled Trial (The Third Multicenter Intrapleural Sepsis Trial - MIST-3).
Rationale: Assessing the early use of video-assisted thoracoscopic surgery (VATS) or intrapleural enzyme therapy (IET) in pleural infection requires a phase III randomized controlled trial (RCT). Objectives: To establish the feasibility of randomization in a surgery-versus-nonsurgery trial as well as the key outcome measures that are important to identify relevant patient-centered outcomes in a subsequent RCT. Methods: The MIST-3 (third Multicenter Intrapleural Sepsis Trial) was a prospective multicenter RCT involving eight U. ⋯ Despite the logistical challenges posed by the coronavirus disease (COVID-19) pandemic, the study met its predefined feasibility criteria, demonstrated potential shortening of length of stay with early surgery, and signals toward earlier resolution of pain and a shortened recovery with IET. The study findings suggest that a definitive phase III study is feasible but highlights important considerations and significant modifications to the design that would be required to adequately assess optimal initial management in pleural infection. The trial was registered on ISRCTN (number 18,192,121).
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Am. J. Respir. Crit. Care Med. · Dec 2023
Letter Randomized Controlled Trial Multicenter StudyThe Interaction of Acute Kidney Injury with Resuscitation Strategy in Sepsis: A Secondary Analysis of a Multicenter, Phase 3, Randomized Trial (CLOVERS).