NCT01232088

Brief Summary

Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338). Standardized color coded labels for user applied syringes enjoy strong support from many health professionals, thinking that this might increase patient safety. Whether this is true or not warrants further research.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
482

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

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

November 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

November 1, 2010

Last Update Submit

October 30, 2015

Conditions

Keywords

drug labellingstandardized drug syringe labellingEuropean ICU

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to assess if standardized drug syringe labelling is used in European ICUs.

    Online survey for ICU physicians (members of the ESICM).

    A period of 90 days.

Secondary Outcomes (1)

  • The second objectives is to assess 1. if standards for drug syringe labelling are similar in European ICUs and 2. if users expect that standardized drug syringe labelling should be delivered by the pharmaceutical industry.

    A period of 90 days

Study Arms (1)

Data collection group: ICU physicians

Online survey for ICU physicians (members of the European Society of Intensive Care Medicine (ESICM)).

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Members of the European Society of Intensive Care Medicine (ESICM)

You may qualify if:

  • Members of the European Society of Intensive Care Medicine (ESICM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Campus Virchow Klinikum/Campus Charité Mitte

Berlin, State of Berlin, 13353/10117, Germany

Location

Related Publications (2)

  • Valentin A, Capuzzo M, Guidet B, Moreno R, Metnitz B, Bauer P, Metnitz P; Research Group on Quality Improvement of the European Society of Intensive Care Medicine (ESICM); Sentinel Events Evaluation (SEE) Study Investigators. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009 Mar 12;338:b814. doi: 10.1136/bmj.b814.

    PMID: 19282436BACKGROUND
  • Balzer F, Wickboldt N, Spies C, Walder B, Goncerut J, Citerio G, Rhodes A, Kastrup M, Boemke W. Standardised drug labelling in intensive care: results of an international survey among ESICM members. Intensive Care Med. 2012 Aug;38(8):1298-305. doi: 10.1007/s00134-012-2569-1. Epub 2012 Apr 20.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 2, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations