A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial
Por:
Heyland, DK, van Zanten, ARH, Grau-Carmona, T, Evans, D, Beishuizen, A, Schouten, J, Hoiting, O, Bordeje, ML, Krell, K, Klein, DJ, Gonzalez, J, Perez, A, Brown, R, James, J, Harris, MS, Jolley, S, Raines, R, Servia-Goixart, L, Perez-Quesada, S, Herrero-Meseguer, JI, Calvo-Herranz, E, Lorencio, C, Peredes, A, Yebenes-Reyes, JC, Garcia-Martinez, MA, Cervera, M, Fernadez-Ortega, JF, Fernandez-Gonzalez, I, van Zanten, A, Stelfox, T and Posadas, J
Publicada:
1 may 2019
Categoría:
Critical care and intensive care medicine
Resumen:
PurposeEnteral feeding intolerance (EFI) is a frequent problem in the intensive care unit (ICU), but current prokinetic agents have uncertain efficacy and safety profiles. The current study compared the efficacy and safety of ulimorelin, a ghrelin agonist, with metoclopramide in the treatment of EFI.MethodsOne hundred twenty ICU patients were randomized 1:1 to ulimorelin or metoclopramide for 5days. EFI was diagnosed by a gastric residual volume (GRV) 500ml. A volume-based feeding protocol was employed, and enteral formulas were standardized. The primary end point was the percentage daily protein prescription (%DPP) received by patients over 5days of treatment. Secondary end points included feeding success, defined as 80% DPP; gastric emptying, assessed by paracetamol absorption; incidences of recurrent intolerance (GRV500ml); vomiting or regurgitation; aspiration, defined by positive tracheal aspirates for pepsin; and pulmonary infection.ResultsOne hundred twenty patients were randomized and received the study drug (ulimorelin 62, metoclopramide 58). Mean APACHE II and SOFA scores were 21.6 and 8.6, and 63.3% of patients had medical reasons for ICU admission. Ulimorelin and metoclopramide resulted in comparable %DPPs over 5days of treatment (median [Q1, Q3]: 82.9% [38.4%, 100.2%] and 82.3% [65.6%, 100.2%], respectively, p=0.49). Five-day rates of feeding success were 67.7% and 70.6% when terminations unrelated to feeding were excluded, and there were no differences in any secondary outcomes or adverse events between the two groups.ConclusionsBoth prokinetic agents achieved similar rates of feeding success, and no safety differences between the two treatment groups were observed.
Filiaciones:
Heyland, DK:
Queens Univ, Kingston, ON, Canada
van Zanten, ARH:
Gelderse Vallei Hosp, Ede, Netherlands
Grau-Carmona, T:
Hosp Univ Doce Octubre, Madrid, Spain
Evans, D:
Ohio State Univ, Columbus, OH 43210 USA
Ohio State Univ, Wexner Med Ctr, Columbus, OH USA
Beishuizen, A:
Med Spectrum Twente, Enschede, Netherlands
Schouten, J:
Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands
Hoiting, O:
Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands
:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
Krell, K:
Eastern Idaho Reg Med Ctr, Idaho Falls, ID USA
Klein, DJ:
Univ Toronto, Toronto, ON, Canada
Gonzalez, J:
Pivotal SL, Madrid, Spain
Perez, A:
Pivotal SL, Madrid, Spain
Brown, R:
Lyric Pharmaceut, San Francisco, CA 94080 USA
James, J:
Lyric Pharmaceut, San Francisco, CA 94080 USA
Harris, MS:
Lyric Pharmaceut, San Francisco, CA 94080 USA
Georgetown Univ, Sch Med, Washington, DC USA
Jolley, S:
Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA
Raines, R:
Rockies Reg Med Ctr, Colorado Springs, CO USA
Servia-Goixart, L:
Hosp Arnau Vilanova, Lleida, Spain
Perez-Quesada, S:
Hosp Gen Alicante, Alicante, Spain
Herrero-Meseguer, JI:
Hosp Univ Bellvitge, Barcelona, Spain
Calvo-Herranz, E:
Hosp Univ Getafe, Getafe, Spain
Lorencio, C:
Hosp Univ Josep Trueta, Girona, Spain
Peredes, A:
Hosp Quronsalud Sur, Alcorcon, Spain
Yebenes-Reyes, JC:
Hosp Mataro, Mataro, Spain
Garcia-Martinez, MA:
Hosp Torrevieja, Torrevieja, Spain
Cervera, M:
Hosp Dr Peset, Valencia, Spain
Fernadez-Ortega, JF:
Hosp Univ Carlos Haya, Malaga, Spain
Fernandez-Gonzalez, I:
Hosp Quiron San Camilo, Madrid, Spain
van Zanten, A:
Gelderse Vallei Hosp, Ede, Netherlands
Stelfox, T:
Univ Alberta, Calgary, AB, Canada
Posadas, J:
Univ Alberta, Calgary, AB, Canada
Green Accepted, Bronze
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