NCT05553054

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,066

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
3 countries

61 active sites

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

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

September 21, 2022

Last Update Submit

April 10, 2026

Conditions

Keywords

Intravenous (IV) drugWasteIntensive Care Unit (ICU)Environmental sustainabilityDrug wastageCare Eco-design

Outcome Measures

Primary Outcomes (1)

  • Ratio of overall wastage in milliliter (mL) of prepared and discarded IV drugs to overall volume in milliliter (mL) of prepared IV drugs.

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

    24 hours

Secondary Outcomes (4)

  • Reason for discarding drug residues

    24 hours

  • Drug residues discarding process

    24 hours

  • Use of enteral administration route

    24 hours

  • Cost of overall IV drug wastage

    24 hours

Study Arms (1)

Intravenous (IV) drugs

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

Other: Quantification of IV drugs wastage

Interventions

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.

Intravenous (IV) drugs

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

  • Patient's opposition to participate in the study or patient family opposition if the patient is not able to be informed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

Centre Hospitalier de Charleville-Mezieres

Charleville-Mézières, Ardennes, 08000, France

Location

CHRU de Strasbourg

Strasbourg, Bas-Rhin, 67098, France

Location

Hôpital Nord

Marseille, Bouches Du Rhône, 13015, France

Location

Centre Hospitalier d'Aurillac

Aurillac, Cantal, 15000, France

Location

Groupe Hospitalier Littoral Atlantique

La Rochelle, Charente-Maritime, 17019, France

Location

CHU de Besançon

Besançon, Doubs, 25000, France

Location

Centre Hospitalier de Montélimar

Montélimar, Drôme, 26216, France

Location

Hôpital privé Claude Galien

Quincy-sous-Sénart, Essonne, 91480, France

Location

HIA Clermont Tonnerre

Brest, Finistère, 29240, France

Location

CHRU de Brest

Brest, Finistère, 29609, France

Location

CHU de Nîmes

Nîmes, Gard, 30900, France

Location

Clinique Saint Augustin

Bordeaux, Gironde, 33000, France

Location

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, Gironde, 33076, France

Location

HIA Robert Picqué

Bordeaux, Gironde, 33140, France

Location

Hôpital Robert Boulin

Libourne, Gironde, 33500, France

Location

CHU de Toulouse - Hôpital Purpan

Toulouse, Haute Garonne, 31059, France

Location

Clinique la Croix du Sud

Quint-Fonsegrives, Haute-Garonne, 31130, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, Haute-Garonne, 31059, France

Location

Clinique Pasteur

Toulouse, Haute-Garonne, 31300, France

Location

Centre Hospitalier Emile Roux

Le Puy-en-Velay, Haute-Loire, 43000, France

Location

Hôpital privé d'Antony

Antony, Hauts-de-Seine, 92160, France

Location

HIA Percy-Clamart

Clamart, Hauts-de-Seine, 92141, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, Hauts-de-Seine, 92200, France

Location

CHU de Rennes

Rennes, Ille-et-Vilaine, 35033, France

Location

CHRU de Tours

Chambray-lès-Tours, Indre-et-Loire, 37170, France

Location

CHU de Grenoble

La Tronche, Isère, 38700, France

Location

Centre Hospitalier de Dax

Dax, Landes, 40100, France

Location

Centre Hospitalier de Mont-de-Marsan

Mont-de-Marsan, Landes, 40024, France

Location

Centre Hospitalier Simone Veil

Blois, Loir-et-Cher, 41000, France

Location

Centre Hospitalier de Saint Nazaire

Saint-Nazaire, Loire-Atlantique, 44600, France

Location

Centre Hospitalier d'Orléans

Orléans, Loiret, 45100, France

Location

Centre Hospitalier de Cahors

Cahors, Lot, 46005, France

Location

CHU d'Angers

Angers, Maine-et-Loire, 49100, France

Location

Centre Hospitalier Mémorial de Saint-Lô

Saint-Lô, Manche, 50000, France

Location

CHU de Reims

Reims, Marne, 51100, France

Location

Centre Hospitalier Bretagne Atlantique de Vannes

Vannes, Morbihan, 56017, France

Location

CHU de Lille - Hôpital Huriez

Lille, Nord, 59037, France

Location

CHU de Lille - Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Centre Hospitalier du Forez

Montbrison, Pays de la Loire Region, 42600, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, Pays de la Loire Region, 42270, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, Puy-de-Dôme, 63003, France

Location

Hôpital Pierre Wertheimer

Bron, Rhône, 69677, France

Location

Hôpital Edouard Herriot

Lyon, Rhône, 69003, France

Location

Clinique de la Sauvegarde

Lyon, Rhône, 69009, France

Location

CHU Félix-Guyon

Saint-Denis, Réunion, 97400, France

Location

CHU de la Réunion

Saint-Pierre, Réunion, 97410, France

Location

Grand Hôpital de l'Est Francilien

Meaux, Seine-et-Marne, 77100, France

Location

CHU d'Amiens

Amiens, Somme, 80054, France

Location

Hôpital Nord Franche-Comté

Trévenans, Territoire De Belfort, 90400, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, Val d'Oise, 95100, France

Location

Hôpital Henri Mondor

Créteil, Val-de-Marne, 94000, France

Location

HIA Sainte Anne

Toulon, Var, 83000, France

Location

Hôpital Sainte Musse

Toulon, Var, 83056, France

Location

CHU de Poitiers

Poitiers, Vienne, 86021, France

Location

Centre Hospitalier de Versailles

Le Chesnay, Yvelines, 78150, France

Location

CHU Dupuytren

Limoges, 87042, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital La Pitié-Salpétrière

Paris, 75013, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Centre Hospitalier de Mayotte

Mamoudzou, 97600, Mayotte

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Related Publications (3)

  • d'Aranda E; GAME-OVER investigators group; Pons S, Chelly J, Atchade E, Bonnet L; SFAR Sustainable Development Committee; Dahyot-Fizelier C; SFAR Critical Care Committee; Kamel T, Giannoni F, Collange O, Besnier E, Schoeffler M, Mayeur N, Quere PL, Marecal L, Pernod C, Geay C, Esnault P, Cinotti R; SFAR Research Network; Cesana M, Cungi PJ. Discarded intravenous medication in the ICU: the GAME-OVER multicenter prospective observational study. Crit Care. 2025 Feb 21;29(1):84. doi: 10.1186/s13054-025-05299-6.

  • Atchade E, Cungi PJ, Pons S, Dahyot-Fizelier C, Cesana M, Lukaszewicz AC, Bouhemad B, Trouiller P, Chelly J, Montravers P, Vardon F, D'Aranda E; SFAR Critical Care Committee; SFAR Sustainability Committee; SFAR Research Network; GAME-OVER Study group; GAME-OVER investigators group. Characteristics of French intensive care units and patients: an ancillary analysis of the GAME-OVER study. BMC Anesthesiol. 2025 Dec 5;26(1):27. doi: 10.1186/s12871-025-03473-5.

  • d'Aranda E, Cungi PJ, Chelly J, Pons S; GAME-OVER Study Group, GAME-OVER Study Investigators, French Society of Anesthesia & Intensive Care Medicine (SFAR) Sustainability; Committee, SFAR Critical Care Committee, and SFAR Research Network; GAME-OVER Study Group, GAME-OVER Study Investigators, French Society of Anesthesia & Intensive Care Medicine (SFAR) Sustainability and Committee, SFAR Critical Care Committee, and SFAR Research Network. Sustainable Intensive Care: Do Not Forget IV to Oral Switch! Crit Care Med. 2026 Jan 1;54(1):218-223. doi: 10.1097/CCM.0000000000006944. Epub 2026 Jan 6. No abstract available.

Study Officials

  • Erwan D'ARANDA, MD

    Sainte-Anne Military Teaching Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

November 8, 2022

Primary Completion

March 15, 2023

Study Completion

March 15, 2023

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations