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

March 29, 2024 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1066

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Chu Dupuytren
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75013
        • Hôpital La Pitié-Salpêtrière
      • Paris, France, 75018
        • Hôpital Bichat
    • Ardennes
      • Charleville-Mézières, Ardennes, France, 08000
        • Centre Hospitalier de Charleville-Mezieres
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67098
        • CHRU de Strasbourg
    • Bouches Du Rhône
      • Marseille, Bouches Du Rhône, France, 13015
        • Hopital Nord
    • Cantal
      • Aurillac, Cantal, France, 15000
        • Centre Hospitalier d'Aurillac
    • Charente-Maritime
      • La Rochelle, Charente-Maritime, France, 17019
        • Groupe Hospitalier Littoral Atlantique
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU de Besancon
    • Drôme
      • Montélimar, Drôme, France, 26216
        • Centre Hospitalier de Montélimar
    • Essonne
      • Quincy-sous-Sénart, Essonne, France, 91480
        • Hôpital Privé Claude Galien
    • Finistère
      • Brest, Finistère, France, 29240
        • HIA Clermont Tonnerre
      • Brest, Finistère, France, 29609
        • CHRU de Brest
    • Gard
      • Nîmes, Gard, France, 30900
        • CHU de Nimes
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Clinique Saint Augustin
      • Bordeaux, Gironde, France, 33076
        • CHU de Bordeaux - Hôpital Pellegrin
      • Bordeaux, Gironde, France, 33140
        • HIA Robert Picqué
      • Libourne, Gironde, France, 33500
        • Hôpital Robert Boulin
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • CHU de Toulouse - Hôpital Purpan
    • Haute-Garonne
      • Quint-Fonsegrives, Haute-Garonne, France, 31130
        • Clinique La Croix du Sud
      • Toulouse, Haute-Garonne, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Toulouse, Haute-Garonne, France, 31300
        • Clinique Pasteur
    • Haute-Loire
      • Le Puy-en-Velay, Haute-Loire, France, 43000
        • Centre Hospitalier Emile ROUX
    • Hauts-de-Seine
      • Antony, Hauts-de-Seine, France, 92160
        • Hopital Prive d'Antony
      • Clamart, Hauts-de-Seine, France, 92141
        • HIA Percy-Clamart
      • Neuilly-sur-Seine, Hauts-de-Seine, France, 92200
        • Hôpital Américain de Paris
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35033
        • CHU de Rennes
    • Indre-et-Loire
      • Chambray-lès-Tours, Indre-et-Loire, France, 37170
        • CHRU De Tours
    • Isère
      • La Tronche, Isère, France, 38700
        • CHU de Grenoble
    • Landes
      • Dax, Landes, France, 40100
        • Centre Hospitalier de Dax
      • Mont-de-Marsan, Landes, France, 40024
        • Centre Hospitalier de Mont-de-Marsan
    • Loir-et-Cher
      • Blois, Loir-et-Cher, France, 41000
        • Centre Hospitalier Simone Veil
    • Loire
      • Montbrison, Loire, France, 42600
        • Centre Hospitalier du Forez
      • Saint-Priest-en-Jarez, Loire, France, 42270
        • CHU DE SAINT-ETIENNE
    • Loire-Atlantique
      • Saint-Nazaire, Loire-Atlantique, France, 44600
        • Centre Hospitalier de Saint Nazaire
    • Loiret
      • Orléans, Loiret, France, 45100
        • Centre Hospitalier d'Orléans
    • Lot
      • Cahors, Lot, France, 46005
        • Centre Hospitalier de Cahors
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49100
        • CHU d'Angers
    • Manche
      • Saint-Lô, Manche, France, 50000
        • Centre Hospitalier Mémorial de Saint-Lô
    • Marne
      • Reims, Marne, France, 51100
        • CHU de Reims
    • Morbihan
      • Vannes, Morbihan, France, 56017
        • Centre Hospitalier Bretagne Atlantique de Vannes
    • Nord
      • Lille, Nord, France, 59037
        • CHU de Lille - Hôpital Huriez
      • Lille, Nord, France, 59037
        • CHU de Lille - Hôpital Roger Salengro
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63003
        • CHU de Clermont-Ferrand
    • Rhône
      • Bron, Rhône, France, 69677
        • Hopital Pierre Wertheimer
      • Lyon, Rhône, France, 69003
        • Hôpital Edouard Herriot
      • Lyon, Rhône, France, 69009
        • Clinique de la Sauvegarde
    • Réunion
      • Saint-Denis, Réunion, France, 97400
        • CHU Félix-Guyon
      • Saint-Pierre, Réunion, France, 97410
        • CHU de la Réunion
    • Seine-et-Marne
      • Meaux, Seine-et-Marne, France, 77100
        • Grand Hôpital de l'Est Francilien
    • Somme
      • Amiens, Somme, France, 80054
        • CHU d'Amiens
    • Territoire De Belfort
      • Trévenans, Territoire De Belfort, France, 90400
        • Hôpital Nord Franche-Comté
    • Val d'Oise
      • Argenteuil, Val d'Oise, France, 95100
        • Centre Hospitalier Victor Dupouy
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Hôpital Henri Mondor
    • Var
      • Toulon, Var, France, 83056
        • Hôpital Sainte Musse
      • Toulon, Var, France, 83000
        • HIA Sainte Anne
    • Vienne
      • Poitiers, Vienne, France, 86021
        • CHU de Poitiers
    • Yvelines
      • Le Chesnay, Yvelines, France, 78150
        • Centre Hospitalier de Versailles
  • Mayotte
      • Mamoudzou, Mayotte, 97600
        • Centre Hospitalier de Mayotte
  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients hospitalized in intensive care units during the 24 hours of data collection.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of overall wastage in milliliter (mL) of prepared and discarded IV drugs to overall volume in milliliter (mL) of prepared IV drugs.
Time Frame: 24 hours
Wastage is defined as any prepared and unused drug that remains in syringe or IV bag.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason for discarding drug residues
Time Frame: 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.
24 hours
Drug residues discarding process
Time Frame: 24 hours
A questionnaire will be used to determine which discarding process are applied by nurses in their usual pratices.
24 hours
Use of enteral administration route
Time Frame: 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.
24 hours
Cost of overall IV drug wastage
Time Frame: 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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborators

Sainte-Anne Military Teaching Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2022

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-CHITS-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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