Evidence map›Paper›PMID 31062046›Full record

Trial reportIntensive care medicine2019

A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial.

Daren K Heyland, Arthur R H van Zanten, Teodoro Grau-Carmona, David Evans, Albertus Beishuizen, Jeroen Schouten, Oscar Hoiting, Maria Luisa Bordejé, Kenneth Krell, David J Klein and 6 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Intensive care medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.3field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Comparison of enteral prucaloprideFrontiers in pharmacology · 2024
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. An examination of gastrointestinal absorption using the acetaminophen absorption test in critically ill patients with COVID-19: A retrospective cohort study.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2021
    Observational
  16. Review
  17. Article
  18. Review
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 11 institutions in 4 countries.

Daren K HeylandQueen's University, Kingston, ON, Canada.
Arthur R H van ZantenGelderse Vallei Hospital, Ede, The Netherlands.
Teodoro Grau-CarmonaHospital Universitario Doce de Octubre, Madrid, Spain.
David EvansOhio State University, Columbus, OH, USA.
Albertus BeishuizenMedisch Spectrum Twente, Enschede, The Netherlands.
Jeroen SchoutenCanisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands.
Oscar HoitingCanisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands.
Maria Luisa BordejéHospital Universitari Germans Trias i Pujol, Badalona, Spain.
Kenneth KrellEastern Idaho Regional Medical Center, Idaho Falls, ID, USA.
David J KleinUniversity of Toronto, Toronto, Canada.
Jesus GonzalezPivotal SL, Madrid, Spain.
Aitor PerezPivotal SL, Madrid, Spain.
Randy BrownLyric Pharmaceuticals, San Francisco, CA, USA.
Joyce JamesLyric Pharmaceuticals, San Francisco, CA, USA.
M Scott HarrisLyric Pharmaceuticals, San Francisco, CA, USA. harris@middleburgconsultants.com.ORCID 0000-0001-5141-5773
Investigators of the PROMOTE LP101-CL-201 Trial
Georgetown University · USCanisius-Wilhelmina Ziekenhuis · NLEastern Idaho Technical College · USHospital Universitari Germans Trias i Pujol · ESHospital Universitario 12 De Octubre · ESMedisch Spectrum Twente · NLPivotal (Spain) · ESQueen's University · CAThe Ohio State University · USZiekenhuis Gelderse Vallei · NLUniversity of Toronto · CA

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Leigh Lamonica · 2012 to 2026
$69.1M
Prevalence of ICU-Acquired Myopathy in Patients with Alcohol Use DisordersK23AA026315 · NIAAA · UNIVERSITY OF COLORADO DENVER · PI JOLLEY, SARAH E · 2018 to 2022
$696k
NIAAA NIH HHS K23 AA026315NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

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 5 days. EFI was diagnosed by a gastric residual volume (GRV) ≥ 500 ml. 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 5 days of treatment. Secondary end points included feeding success, defined as 80% DPP; gastric emptying, assessed by paracetamol absorption; incidences of recurrent intolerance (GRV ≥ 500 ml); 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 5 days 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.

Indexed as

AdultAgedAntiemeticsAPACHECanadaCritical IllnessDouble-Blind MethodEnteral NutritionFemaleGastric EmptyingHumansIntensive Care UnitsMacrocyclic CompoundsMaleMetoclopramideMiddle AgedAntiemeticsMacrocyclic CompoundsMetoclopramideulimorelinEnteral feeding intoleranceGastric residual volumeMetoclopramidePROMOTEUlimorelinVolume-based feeding

Identifiers

PMID31062046
PMCPMC9121863
OpenAlexW2943965773

What OpenQuestion holds

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LicenceTDM
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.