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NCT05553054 Clinical Trial

Drug Wastage : Observational Study in Intensive Care Units in France

Drug Use Clinical Trial

— GAME-OVER  

Official title:
Drug Wastage : Observational Study in Intensive Care Units in France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05553054
Other study ID # 2022-CHITS-009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 8, 2022
Est. completion date March 15, 2023

Study information
Verified date March 2024
Source Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 1066
Est. completion date March 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France CHU d'Amiens Amiens Somme
France CHU d'Angers Angers Maine-et-Loire
France Hôpital privé d'Antony Antony Hauts-de-Seine
France Centre Hospitalier Victor Dupouy Argenteuil Val d'Oise
France Centre Hospitalier d'Aurillac Aurillac Cantal
France CHU de Besançon Besançon Doubs
France Centre Hospitalier Simone Veil Blois Loir-et-Cher
France CHU de Bordeaux - Hôpital Pellegrin Bordeaux Gironde
France Clinique Saint Augustin Bordeaux Gironde
France HIA Robert Picqué Bordeaux Gironde
France CHRU de Brest Brest Finistère
France HIA Clermont Tonnerre Brest Finistère
France Hôpital Pierre Wertheimer Bron Rhône
France Centre Hospitalier de Cahors Cahors Lot
France CHRU de Tours Chambray-lès-Tours Indre-et-Loire
France Centre Hospitalier de Charleville-Mezieres Charleville-Mézières Ardennes
France HIA Percy-Clamart Clamart Hauts-de-Seine
France CHU de Clermont-Ferrand Clermont-Ferrand Puy-de-Dôme
France Hôpital Henri Mondor Créteil Val-de-Marne
France Centre Hospitalier de Dax Dax Landes
France Groupe Hospitalier Littoral Atlantique La Rochelle Charente-Maritime
France CHU de Grenoble La Tronche Isère
France Centre Hospitalier de Versailles Le Chesnay Yvelines
France Centre Hospitalier Emile Roux Le Puy-en-Velay Haute-Loire
France Hôpital Robert Boulin Libourne Gironde
France CHU de Lille - Hôpital Huriez Lille Nord
France CHU de Lille - Hôpital Roger Salengro Lille Nord
France CHU Dupuytren Limoges
France Clinique de la Sauvegarde Lyon Rhône
France Hôpital Edouard Herriot Lyon Rhône
France Hôpital Nord Marseille Bouches Du Rhône
France Grand Hôpital de l'Est Francilien Meaux Seine-et-Marne
France Centre Hospitalier de Mont-de-Marsan Mont-de-Marsan Landes
France Centre Hospitalier du Forez Montbrison Loire
France Centre Hospitalier de Montélimar Montélimar Drôme
France Hôpital Américain de Paris Neuilly-sur-Seine Hauts-de-Seine
France CHU de Nîmes Nîmes Gard
France Centre Hospitalier d'Orléans Orléans Loiret
France Hôpital Bichat Paris
France Hôpital La Pitié-Salpétrière Paris
France Hôpital Lariboisière Paris
France CHU de Poitiers Poitiers Vienne
France Hôpital privé Claude Galien Quincy-sous-Sénart Essonne
France Clinique la Croix du Sud Quint-Fonsegrives Haute-Garonne
France CHU de Reims Reims Marne
France CHU de Rennes Rennes Ille-et-Vilaine
France CHU Félix-Guyon Saint-Denis Réunion
France Centre Hospitalier Mémorial de Saint-Lô Saint-Lô Manche
France Centre Hospitalier de Saint Nazaire Saint-Nazaire Loire-Atlantique
France CHU de la Réunion Saint-Pierre Réunion
France CHU de Saint-Etienne Saint-Priest-en-Jarez Loire
France CHRU de Strasbourg Strasbourg Bas-Rhin
France HIA Sainte Anne Toulon Var
France Hôpital Sainte Musse Toulon Var
France CHU de Toulouse - Hôpital Purpan Toulouse Haute Garonne
France CHU de Toulouse - Hôpital Rangueil Toulouse Haute-Garonne
France Clinique Pasteur Toulouse Haute-Garonne
France Hôpital Nord Franche-Comté Trévenans Territoire De Belfort
France Centre Hospitalier Bretagne Atlantique de Vannes Vannes Morbihan
Mayotte Centre Hospitalier de Mayotte Mamoudzou
Monaco Centre Hospitalier Princesse Grace Monaco

Sponsors (2)
Lead Sponsor Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Sainte-Anne Military Teaching Hospital

Countries where clinical trial is conducted

France,  Mayotte,  Monaco, 

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