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001-es BibID:	BIBFORM117248
035-os BibID:	(cikkazonosító)100782 (Scopus)85178352005
Első szerző:	de Jonge, Jeroen C.
Cím:	Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS) : a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment / de Jonge Jeroen C., Sluis Wouter M., Reinink Hendrik, Bath Philip M., Woodhouse Lisa J., Zweedijk Berber, van de Beek Diederik, Aamodt Anne Hege, Alpers Iris, Ciccone Alfonso, Csiba Laszlo, Demotes Jacques, Korv Janika, Kurkowska-Jastrzebska Iwona, Dawson Jesse, Macleod Malcolm R., Ntaios George, Poli Sven, Milionis Haralampos, Ricci Stefano, Cenciarelli Silvia, Candelaresi Paolo, de Bruijn Sebastiaan F. T. M., Pathansali Rohan, Krishnan Kailash, Clarke Brian, Thomalla Götz, van der Worp H. Bart, PRECIOUS investigators
Dátum:	2024
ISSN:	2666-7762
Megjegyzések:	Background: Infections and fever after stroke are associated with poor functional outcome or death. We assessed whether prophylactic treatment with anti-emetic, antibiotic, or antipyretic medication would improve functional outcome in older patients with acute stroke. Methods: We conducted an international, 2?2?2-factorial, randomised, controlled, open-label trial with blinded outcome assessment in patients aged 66 years or older with acute ischaemic stroke or intracerebral haemorrhage and a score on the National Institutes of Health Stroke Scale ? 6. Patients were randomly allocated (1:1) to metoclopramide (oral, rectal, or intravenous; 10 mg thrice daily) vs. no metoclopramide, ceftriaxone (intravenous; 2000 mg once daily) vs. no ceftriaxone, and paracetamol (oral, rectal, or intravenous; 1000 mg four times daily) vs. no paracetamol, started within 24 h after symptom onset and continued for four days. All participants received standard of care. The target sample size was 3800 patients. The primary outcome was the score on the modified Rankin Scale (mRS) at 90 days analysed with ordinal logistic regression and reported as an adjusted common odds ratio (an acOR < 1 suggests benefit and an acOR > 1 harm). This trial is registered (ISRCTN82217627). Findings: From April 2016 through June 2022, 1493 patients from 67 European sites were randomised to metoclopramide (n = 704) or no metoclopramide (n = 709), ceftriaxone (n = 594) or no ceftriaxone (n = 482), and paracetamol (n = 706) or no paracetamol (n = 739), of whom 1471 were included in the intention-to-treat analysis. Prophylactic use of study medication did not significantly alter the primary outcome at 90 days: metoclopramide vs. no metoclopramide (adjusted common odds ratio [acOR], 1.01; 95% CI 0.81?1.25), ceftriaxone vs. no ceftriaxone (acOR 0.99; 95% CI 0.77?1.27), paracetamol vs. no paracetamol (acOR 1.19; 95% CI 0.96?1.47). The study drugs were safe and not associated with an increased incidence of serious adverse events. Interpretation: We observed no sign of benefit of prophylactic use of metoclopramide, ceftriaxone, or paracetamol during four days in older patients with a moderately severe to severe acute stroke. Funding: This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No: 634809.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Fever Infection Intracerebral haemorrhage Ischaemic stroke Pneumonia Stroke
Megjelenés:	The Lancet Regional Health - Europe. - 36 (2024), p. 1-15. -
További szerzők:	Sluis, Wouter M. Reinink, Hendrik Bath, Philip M. Woodhouse, Lisa J. Zweedijk, Berber van de Beek, Diederik Aamodt, Anne Hege Alpers, Iris Ciccone, Alfonso Csiba László (1952-) (neurológus, pszichiáter) Demotes-Mainard, Jacques Kõrv, Janika Kurkowska-Jastrzebska, Iwona Dawson, Jesse Macleod, Malcolm R. Ntaios, George Poli, Sven Milionis, Haralampos Ricci, Stefano Cenciarelli, Silvia Candelaresi, Paolo de Bruijn, Sebastiaan F. T. M. Pathansali, Rohan Krishnan, Kailash Clarke, Brian Thomalla, Götz van der Worp, H. Bart PRECIOUS investigators
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