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Designing phase 3 sepsis trials: application of learned experiences from critical care trials in acute heart failure
- Source :
- Journal of intensive care, vol 4, iss 1, Journal of Intensive Care, Journal of Intensive Care, 2016, 4, pp.24. ⟨10.1186/s40560-016-0151-6⟩, Journal of intensive care, Vol. 4, no. 1, p. 24 [1-11] (2016), Journal of Intensive Care 4, 24 (2016). doi:10.1186/s40560-016-0151-6, Journal of Intensive Care, BioMed Central, 2016, 4, pp.24. ⟨10.1186/s40560-016-0151-6⟩
- Publication Year :
- 2016
- Publisher :
- eScholarship, University of California, 2016.
-
Abstract
- WOS: 000373260700001<br />PubMed ID: 27034779<br />Substantial attention and resources have been directed to improving outcomes of patients with critical illnesses, in particular sepsis, but all recent clinical trials testing various interventions or strategies have failed to detect a robust benefit on mortality. Acute heart failure is also a critical illness, and although the underlying etiologies differ, acute heart failure and sepsis are critical care illnesses that have a high mortality in which clinical trials have been difficult to conduct and have not yielded effective treatments. Both conditions represent a syndrome that is often difficult to define with a wide variation in patient characteristics, presentation, and standard management across institutions. Referring to past experiences and lessons learned in acute heart failure may be informative and help frame research in the area of sepsis. Academic heart failure investigators and industry have worked closely with regulators for many years to transition acute heart failure trials away from relying on dyspnea assessments and all-cause mortality as the primary measures of efficacy, and recent trials have been designed to assess novel clinical composite endpoints assessing organ dysfunction and mortality while still assessing all-cause mortality as a separate measure of safety. Applying the lessons learned in acute heart failure trials to severe sepsis and septic shock trials might be useful to advance the field. Novel endpoints beyond all-cause mortality should be considered for future sepsis trials.<br />NHLBI NIH HHS [F31 HL127947]
- Subjects :
- medicine.medical_specialty
Clinical Sciences
Psychological intervention
Heart failure
Review
030204 cardiovascular system & hematology
Critical Care and Intensive Care Medicine
Phase (combat)
Sepsis
03 medical and health sciences
Clinical trials as topic
0302 clinical medicine
medicine
030212 general & internal medicine
Mortality
Intensive care medicine
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology
Septic shock
business.industry
Organ dysfunction
medicine.disease
Multiple organ failure
3. Good health
Clinical trial
Etiology
medicine.symptom
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Subjects
Details
- ISSN :
- 20520492
- Database :
- OpenAIRE
- Journal :
- Journal of intensive care, vol 4, iss 1, Journal of Intensive Care, Journal of Intensive Care, 2016, 4, pp.24. ⟨10.1186/s40560-016-0151-6⟩, Journal of intensive care, Vol. 4, no. 1, p. 24 [1-11] (2016), Journal of Intensive Care 4, 24 (2016). doi:10.1186/s40560-016-0151-6, Journal of Intensive Care, BioMed Central, 2016, 4, pp.24. ⟨10.1186/s40560-016-0151-6⟩
- Accession number :
- edsair.doi.dedup.....8bdaaa9f635b95f1cb0ba3dd2bb340e9