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GAME-OVER: Drug Wastage : Observational Study in Intensive Care Units in France

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (Other)
Overall Status
Recruiting
CT.gov ID
NCT05553054
Collaborator
Hôpital d'instruction des armées Sainte-Anne (Other)
240
Enrollment
62
Locations
1.8
Anticipated Duration (Months)
3.9
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Environmental awareness leads medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare.

GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

Condition or Disease Intervention/Treatment Phase
  • Other: Quantification of IV drugs wastage

Detailed Description

Observational study with data collection during a 24-hour business day. Data collected refer to healthcare team's practices and patients.

Collection starts when day shift starts (at 7:00 am) and ends when night shift leaves (at 7:00 am the following day).

Study Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Drug Wastage : Observational Study in Intensive Care Units in France
Actual Study Start Date :
Nov 8, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Intravenous (IV) drugs

Patient and prepared/administrated/discarded IV drugs data will be collected during 24 hours.

Other: Quantification of IV drugs wastage
Drugs are prescribed depending on physician discretion. Specific collection bins are provided to ICU. Healthcare teams discard syringes labelled with name and dilution which have been used to prepare drugs into these bins. After 24 hours of collection, bins are analyzed by investigators.

Outcome Measures

Primary Outcome Measures

  1. Ratio of overall wastage in milliliter (mL) of prepared and discarded IV drugs to overall volume in milliliter (mL) of prepared IV drugs. [24 hours]

    Wastage is defined as any prepared and unused drug that remains in syringe or IV bag.

Secondary Outcome Measures

  1. Reason for discarding drug residues [24 hours]

    A questionnaire will be fulfilled by healthcare teams with the following possible categories: 1/ prepared in advance and not used ; 2/ systematic change at fixed times ; 3/ prescription change ; 4/ change by anticipation of care ; 5/ drug no longer needed ; 6/ preparation error ; 7/ other reason.

  2. Drug residues discarding process [24 hours]

    A questionnaire will be used to determine which discarding process are applied by nurses in their usual pratices.

  3. Use of enteral administration route [24 hours]

    Use of enteral administration route versus per os and IV routes will be analyzed for paracetamol and proton pump inhibitor according to the accessibility of enteral route and the reason and the date of patient entry in ICU.

  4. Cost of overall IV drug wastage [24 hours]

    Estimated cost of drug residues will be evaluated for each drug, according to the reason for discarding, by the following formula : volume of discarded IV drugs x theoretical price

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients hospitalized in intensive care units during the 24 hours of data collection.
Exclusion Criteria:
  • Patient's opposition to participate in the study or patient family opposition if the patient is not able to be informed.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier de Charleville-Mezieres Charleville-Mézières Ardennes France 08000
2 CHRU de Strasbourg Strasbourg Bas-Rhin France 67098
3 Hôpital Nord Marseille Bouches Du Rhône France 13015
4 Centre Hospitalier d'Aurillac Aurillac Cantal France 15000
5 Groupe Hospitalier Littoral Atlantique La Rochelle Charente-Maritime France 17019
6 CHU de Besançon Besançon Doubs France 25000
7 Centre Hospitalier de Montélimar Montélimar Drôme France 26216
8 Hôpital privé Claude Galien Quincy-sous-Sénart Essonne France 91480
9 HIA Clermont Tonnerre Brest Finistère France 29240
10 CHRU de Brest Brest Finistère France 29609
11 CHU de Nîmes Nîmes Gard France 30900
12 Clinique Saint Augustin Bordeaux Gironde France 33000
13 CHU de Bordeaux - Hôpital Pellegrin Bordeaux Gironde France 33076
14 Hôpital Robert Boulin Libourne Gironde France 33500
15 CHU de Bordeaux - Hôpital Haut-Lévêque Pessac Gironde France 33600
16 CHU de Toulouse - Hôpital Purpan Toulouse Haute Garonne France 31059
17 Clinique la Croix du Sud Quint-Fonsegrives Haute-Garonne France 31130
18 CHU de Toulouse - Hôpital Rangueil Toulouse Haute-Garonne France 31059
19 Clinique Pasteur Toulouse Haute-Garonne France 31300
20 Centre Hospitalier Emile Roux Le Puy-en-Velay Haute-Loire France 43000
21 Hôpital privé d'Antony Antony Hauts-de-Seine France 92160
22 HIA Percy-Clamart Clamart Hauts-de-Seine France 92141
23 Hôpital Américain de Paris Neuilly-sur-Seine Hauts-de-Seine France 92200
24 CHU de Rennes Rennes Ille-et-Vilaine France 35033
25 CHRU de Tours Chambray-lès-Tours Indre-et-Loire France 37170
26 CHU de Grenoble La Tronche Isère France 38700
27 Centre Hospitalier de Dax Dax Landes France 40100
28 Centre Hospitalier de Mont-de-Marsan Mont-de-Marsan Landes France 40024
29 Centre Hospitalier Simone Veil Blois Loir-et-Cher France 41000
30 Centre Hospitalier de Saint Nazaire Saint-Nazaire Loire-Atlantique France 44600
31 Centre Hospitalier d'Orléans Orléans Loiret France 45100
32 Centre Hospitalier du Forez Montbrison Loire France 42600
33 CHU de Saint-Etienne Saint-Priest-en-Jarez Loire France 42270
34 Centre Hospitalier de Cahors Cahors Lot France 46005
35 CHU d'Angers Angers Maine-et-Loire France 49100
36 Centre Hospitalier Mémorial de Saint-Lô Saint-Lô Manche France 50000
37 CHU de Reims Reims Marne France 51100
38 Centre Hospitalier de Mayotte Mamoudzou Mayotte France 97600
39 Centre Hospitalier Bretagne Atlantique de Vannes Vannes Morbihan France 56017
40 Centre Hospitalier Pierre Beregovoy Nevers Nièvre France 58000
41 CHU de Lille - Hôpital Huriez Lille Nord France 59037
42 CHU de Lille - Hôpital Roger Salengro Lille Nord France 59037
43 CHU de Clermont-Ferrand Clermont-Ferrand Puy-de-Dôme France 63003
44 Hôpital Pierre Wertheimer Bron Rhône France 69677
45 Hôpital Edouard Herriot Lyon Rhône France 69003
46 Clinique de la Sauvegarde Lyon Rhône France 69009
47 CHU Félix-Guyon Saint-Denis Réunion France 97400
48 CHU de la Réunion Saint-Pierre Réunion France 97410
49 Grand Hôpital de l'Est Francilien Meaux Seine-et-Marne France 77100
50 CHU d'Amiens Amiens Somme France 80054
51 Hôpital Nord Franche-Comté Trévenans Territoire De Belfort France 90400
52 Centre Hospitalier Victor Dupouy Argenteuil Val d'Oise France 95100
53 Hôpital Henri Mondor Créteil Val-de-Marne France 94000
54 HIA Sainte Anne Toulon Var France 83000
55 Hôpital Sainte Musse Toulon Var France 83056
56 CHU de Poitiers Poitiers Vienne France 86021
57 Centre Hospitalier de Versailles Le Chesnay Yvelines France 78150
58 CHU Dupuytren Limoges France 87042
59 Hôpital Lariboisière Paris France 75010
60 Hôpital Saint Antoine Paris France 75012
61 Hôpital Bichat Paris France 75018
62 Centre Hospitalier Princesse Grace Monaco Monaco 98000

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
  • Hôpital d'instruction des armées Sainte-Anne

Investigators

  • Study Director: Erwan D'ARANDA, MD, Sainte-Anne Military Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:
NCT05553054
Other Study ID Numbers:
  • 2022-CHITS-009
First Posted:
Sep 23, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Intravenous (IV) drug
Waste
Intensive Care Unit (ICU)
Environmental sustainability
Drug wastage
Care Eco-design

Study Results

No Results Posted as of Dec 22, 2022