Evidence map›Paper›PMID 28599676›Full record

Trial reportCritical care (London, England)2017

A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial.

Paul E Wischmeyer, Michel Hasselmann, Christine Kummerlen, Rosemary Kozar, Demetrios James Kutsogiannis, Constantine J Karvellas, Beth Besecker, David K Evans, Jean-Charles Preiser, Leah Gramlich and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Critical care (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01206166 (A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients), which is not on this map. Cited by 52 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 7 pooled it
11.8field-weighted citation impact, top 1% 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.

NCT01206166 phase3terminatednot on this map

A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)

TypeinterventionalSponsorClinical Evaluation Research Unit at Kingston General HospitalRan2011 to 2015Enrolled125ConditionsCritical Illness, Acute Respiratory FailureArmsOlimel (5.7%E / N9E)
3 · Its place in the literature

Who cites it

52 citing papers in PubMed, 7 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
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  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Observational
  13. Review
  14. Review
  15. Article
  16. Safety and quality of parenteral nutrition: Areas for improvement and future perspectives.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024
    Article
  17. Article
  18. Risk factors for carbapenem-resistantJournal of preventive medicine and hygiene · 2023
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 4 countries.

Paul E WischmeyerDepartment of Anesthesiology and Surgery and Duke Clinical Research Institute, Duke University School of Medicine, DUMC, Box 3094, Mail # 41, 2301 Erwin Road, 5692 HAFS, Durham, NC, 27710, USA. Paul.Wischmeyer@Duke.edu.
Michel HasselmannFaculté de Médecine de l'Université de Strasbourg, Centre Hospitalier Universitaire de Strasbourg Nouvel Hȏpital Civil, Strasbourg Cedex, France.
Christine KummerlenFaculté de Médecine de l'Université de Strasbourg, Centre Hospitalier Universitaire de Strasbourg Nouvel Hȏpital Civil, Strasbourg Cedex, France.
Rosemary KozarShock Trauma Center, University of Maryland Medical Center, University of Maryland, Baltimore, MD, USA.
Demetrios James KutsogiannisDepartment of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Constantine J KarvellasDivisions of Gastroenterology and Critical Care Medicine, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada.
Beth BeseckerDivision of Pulmonary, Critical Care, Allergy & Sleep Medicine, Ohio State University Medical Center, Ohio State University, Columbus, OH, USA.
David K EvansDepartment of Surgery, The Ohio State University Medical Center, Ohio State University, Columbus, OH, USA.
Jean-Charles PreiserDepartment of Intensive Care, Universite Libre de Bruxelles, Erasme University Hospital, Brussels, Belgium.
Leah GramlichDepartment of Medicine, Division of Gastroenterology, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada.
Khursheed JeejeebhoyDept. of Gastrenterology, University of Toronto, Toronto, ON, Canada.
Rupinder DhaliwalClinical Evaluation Research Unit, Kingston General Hospital, Queen's University, Kingston, ON, Canada.
Xuran JiangClinical Evaluation Research Unit, Kingston General Hospital, Queen's University, Kingston, ON, Canada.
Andrew G DayClinical Evaluation Research Unit, Kingston General Hospital, Queen's University, Kingston, ON, Canada.
Daren K HeylandClinical Evaluation Research Unit, Kingston General Hospital, Queen's University, Kingston, ON, Canada.
Clinical Evaluation Research Unit · CAUniversity of Alberta Hospital · CAClinical Research Institute · USHôpital Civil, Strasbourg · FRKingston General Hospital · CAQueen's University · CAThe Ohio State University · USThe Ohio State University Wexner Medical Center · USUniversité de Strasbourg · FRUniversité Libre de Bruxelles · BEUniversity of Alberta · CAUniversity of Maryland, Baltimore · USUniversity of Toronto · CA

Funding

Supplemental Parenteral Nutrition to Reduce Death in Malnourished ICU PatientsR34HL109369 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI HEYLAND, DAREN KEITH, WISCHMEYER, PAUL E · 2012 to 2014
$568k
NHLBI NIH HHS R34 HL109369
6 · The paper itself

Abstract

backgroundNutrition guidelines recommendations differ on the use of parenteral nutrition (PN), and existing clinical trial data are inconclusive. Our recent observational data show that amounts of energy/protein received early in the intensive care unit (ICU) affect patient mortality, particularly for inadequate nutrition intake in patients with body mass indices (BMIs) of <25 or >35. Thus, we hypothesized increased nutrition delivery via supplemental PN (SPN) + enteral nutrition (EN) to underweight and obese ICU patients would improve 60-day survival and quality of life (QoL) versus usual care (EN alone).

methodsIn this multicenter, randomized, controlled pilot trial completed in 11 centers across four countries, adult ICU patients with acute respiratory failure expected to require mechanical ventilation for >72 hours and with a BMI of <25 or ≥35 were randomized to receive EN alone or SPN + EN to reach 100% of their prescribed nutrition goal for 7 days after randomization. The primary aim of this pilot trial was to achieve a 30% improvement in nutrition delivery.

resultsIn total, 125 patients were enrolled. Over the first 7 post-randomization ICU days, patients in the SPN + EN arm had a 26% increase in delivered calories and protein, whereas patients in the EN-alone arm had a 22% increase (both p < 0.001). Surgical ICU patients received poorer EN nutrition delivery and had a significantly greater increase in calorie and protein delivery when receiving SPN versus medical ICU patients. SPN proved feasible to deliver with our prescribed protocol. In this pilot trial, no significant outcome differences were observed between groups, including no difference in infection risk. Potential, although statistically insignificant, trends of reduced hospital mortality and improved discharge functional outcomes and QoL outcomes in the SPN + EN group versus the EN-alone group were observed.

conclusionsProvision of SPN + EN significantly increased calorie/protein delivery over the first week of ICU residence versus EN alone. This was achieved with no increased infection risk. Given feasibility and consistent encouraging trends in hospital mortality, QoL, and functional endpoints, a full-scale trial of SPN powered to assess these clinical outcome endpoints in high-nutritional-risk ICU patients is indicated-potentially focusing on the more poorly EN-fed surgical ICU setting.

trial registrationNCT01206166.

Indexed as

OverweightParenteral NutritionThinnessAdultAgedBody Mass IndexChi-Square DistributionCritical IllnessEnergy IntakeFemaleHospital MortalityHumansIntensive Care UnitsLength of StayMaleMiddle AgedCalorie deliveryCritical careIntensive careMalnutritionParenteral NutritionProteinQuality of life

Identifiers

PMID28599676
PMCPMC5466764
OpenAlexW2622656909

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.