NCT03270345

Brief Summary

The objective of this study is to provide an up-to-date, global picture of the extent and patterns of pressure injuries in ICUs. Point prevalence studies are only of value when performed on a vast scale. To sample a representative cohort, it is the intention to recruit about 1200 ICUs with all continents covered and as many countries as possible within each continent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

August 29, 2017

Last Update Submit

February 11, 2019

Conditions

Keywords

DecubitusPressureUlcerInjuriesSoresIntensive care

Outcome Measures

Primary Outcomes (1)

  • major risk factors for pressure injury development.

    Pressures injury stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance. Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure injuries.

    on the data collection day of 18 May 2018 (84 days follow-up)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All , adult ICU patients present in the ICU.

You may qualify if:

  • All adult patients (\>18 years of age) present on the date of data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All Centers From All Over the World Willing to Contribute Are Welcome

Brussels, Belgium

Location

Related Publications (19)

  • Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing. 2004 May;33(3):230-5. doi: 10.1093/ageing/afh086.

    PMID: 15082426BACKGROUND
  • Keller BP, Wille J, van Ramshorst B, van der Werken C. Pressure ulcers in intensive care patients: a review of risks and prevention. Intensive Care Med. 2002 Oct;28(10):1379-88. doi: 10.1007/s00134-002-1487-z. Epub 2002 Sep 7.

    PMID: 12373461BACKGROUND
  • Blot S, Cankurtaran M, Petrovic M, Vandijck D, Lizy C, Decruyenaere J, Danneels C, Vandewoude K, Piette A, Vershraegen G, Van Den Noortgate N, Peleman R, Vogelaers D. Epidemiology and outcome of nosocomial bloodstream infection in elderly critically ill patients: a comparison between middle-aged, old, and very old patients. Crit Care Med. 2009 May;37(5):1634-41. doi: 10.1097/CCM.0b013e31819da98e.

    PMID: 19325489BACKGROUND
  • Iranmanesh S, Rafiei H, Sabzevari S. Relationship between Braden scale score and pressure ulcer development in patients admitted in trauma intensive care unit. Int Wound J. 2012 Jun;9(3):248-52. doi: 10.1111/j.1742-481X.2011.00852.x. Epub 2011 Sep 13.

    PMID: 21910830BACKGROUND
  • Manzano F, Navarro MJ, Roldan D, Moral MA, Leyva I, Guerrero C, Sanchez MA, Colmenero M, Fernandez-Mondejar E; Granada UPP Group. Pressure ulcer incidence and risk factors in ventilated intensive care patients. J Crit Care. 2010 Sep;25(3):469-76. doi: 10.1016/j.jcrc.2009.09.002. Epub 2009 Oct 30.

    PMID: 19879730BACKGROUND
  • Nijs N, Toppets A, Defloor T, Bernaerts K, Milisen K, Van Den Berghe G. Incidence and risk factors for pressure ulcers in the intensive care unit. J Clin Nurs. 2009 May;18(9):1258-66. doi: 10.1111/j.1365-2702.2008.02554.x. Epub 2008 Dec 11.

    PMID: 19077028BACKGROUND
  • Terekeci H, Kucukardali Y, Top C, Onem Y, Celik S, Oktenli C. Risk assessment study of the pressure ulcers in intensive care unit patients. Eur J Intern Med. 2009 Jul;20(4):394-7. doi: 10.1016/j.ejim.2008.11.001. Epub 2008 Dec 6.

    PMID: 19524181BACKGROUND
  • Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.

    PMID: 25271389BACKGROUND
  • Matos LS, Duarte NLV, Minetto RdCs, (2010) Incidence and prevalence of ulcer for pressure in CTI of a Public Hospital of DF. Revista Eletronica de Enfermagem 12: 719-726

    BACKGROUND
  • European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel (2009) Prevention and treatment of pressure ulcers: quick reference guide. National Pressure Ulcer Advisory Panel, Washington DC

    BACKGROUND
  • Schafer JL. Multiple imputation: a primer. Stat Methods Med Res. 1999 Mar;8(1):3-15. doi: 10.1177/096228029900800102.

    PMID: 10347857BACKGROUND
  • Schafer JL, Olsen MK. Multiple Imputation for Multivariate Missing-Data Problems: A Data Analyst's Perspective. Multivariate Behav Res. 1998 Oct 1;33(4):545-71. doi: 10.1207/s15327906mbr3304_5.

    PMID: 26753828BACKGROUND
  • Van Messem M, Varewyck M: Evaluating hospital peformance Risk Standard package. Ghent: Ghent University; 2015

    BACKGROUND
  • Varewyck M, Vansteelandt S, Eriksson M, Goetghebeur E. On the practice of ignoring center-patient interactions in evaluating hospital performance. Stat Med. 2016 Jan 30;35(2):227-38. doi: 10.1002/sim.6634. Epub 2015 Aug 24.

    PMID: 26303843BACKGROUND
  • Firth D: Bias Reduction of Maximum Likelihood Estimates.Biometrika Vol. 80, No. 1 (Mar., 1993), pp. 27-38

    BACKGROUND
  • Dejonckheere M, Antonelli M, Arvaniti K, Blot K, CreaghBrown B, de Lange DW, De Waele J, Deschepper M, Dikmen Y, Dimopoulos G, Eckmann C, Francois G, Girardis M, Koulenti D, Labeau S, Lipman J, Lipovestky F, Maseda E, Montravers P, Mikstacki A, Paiva J, Pereyra C, Rello J, Timsit J, Vogelaers D, Blot S; Abdominal Sepsis Study (AbSeS) group on behalf of the Trials Group of the European Society of Intensive Care Medicine. Epidemiology and risk factors for mortality in critically ill patients with pancreatic infection. J Intensive Med. 2023 Aug 30;4(1):81-93. doi: 10.1016/j.jointm.2023.06.004. eCollection 2024 Jan.

  • Rubulotta F, Brett S, Boulanger C, Blackwood B, Deschepper M, Labeau SO, Blot S; UK Collaborating Site Investigators; DecubICUs study team and the European Society of Intensive Care Medicine Trials' Group UK Collaborators. Prevalence of skin pressure injury in critical care patients in the UK: results of a single-day point prevalence evaluation in adult critically ill patients. BMJ Open. 2022 Nov 23;12(11):e057010. doi: 10.1136/bmjopen-2021-057010.

  • De Pascale G, Antonelli M, Deschepper M, Arvaniti K, Blot K, Brown BC, de Lange D, De Waele J, Dikmen Y, Dimopoulos G, Eckmann C, Francois G, Girardis M, Koulenti D, Labeau S, Lipman J, Lipovetsky F, Maseda E, Montravers P, Mikstacki A, Paiva JA, Pereyra C, Rello J, Timsit JF, Vogelaers D, Blot S; Abdominal Sepsis Study (AbSeS) group and the Trials Group of the European Society of Intensive Care Medicine. Poor timing and failure of source control are risk factors for mortality in critically ill patients with secondary peritonitis. Intensive Care Med. 2022 Nov;48(11):1593-1606. doi: 10.1007/s00134-022-06883-y. Epub 2022 Sep 23.

  • Arvaniti K, Dimopoulos G, Antonelli M, Blot K, Creagh-Brown B, Deschepper M, de Lange D, De Waele J, Dikmen Y, Eckmann C, Einav S, Francois G, Fjeldsoee-Nielsen H, Girardis M, Jovanovic B, Lindner M, Koulenti D, Labeau S, Lipman J, Lipovestky F, Makikado LDU, Maseda E, Mikstacki A, Montravers P, Paiva JA, Pereyra C, Rello J, Timsit JF, Tomescu D, Vogelaers D, Blot S; Abdominal Sepsis Study (AbSeS) Group on behalf of the Trials Group of the European Society of Intensive Care Medicine. Epidemiology and age-related mortality in critically ill patients with intra-abdominal infection or sepsis: an international cohort study. Int J Antimicrob Agents. 2022 Jul;60(1):106591. doi: 10.1016/j.ijantimicag.2022.106591. Epub 2022 Apr 20.

MeSH Terms

Conditions

Pressure UlcerUlcerWounds and Injuries

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stijn BLOT

    Full Professor, Dept. of Internal Medicine, Faculty of Medicine & Health Science, Ghent University, Belgium

    PRINCIPAL INVESTIGATOR
  • Sonia LABEAU

    Lecturer at University College Ghent, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 1, 2017

Study Start

May 15, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations