Clinical trial • Phase IV • Other
Isoflurane for Critical condition
Phase IV trial of Isoflurane for Critical condition.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Critical condition
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-11-2024
- First CTIS Authorization Date
- 14-03-2025
Trial design
Randomised, open-label, propofol fresenius 20 mg/ml emulsion for injection/infusion (intravenous sedation). dose and schedule not specified in trial documents provided.-controlled Phase IV trial across 28 sites in Spain.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Propofol Fresenius 20 mg/ml emulsion for injection/infusion (intravenous sedation). Dose and schedule not specified in trial documents provided.
- Target Sample Size
- 620
- Trial Duration For Participant
- 90
Eligibility
Recruits 620 No vulnerable population selected. Informed consent is required and 'Lack of informed consent' is listed as an exclusion criterion. Subject information and informed consent documents are provided (including a version for legal representative), indicating that consent may be obtained from a legal representative where applicable; no paediatric assent is applicable because minimum age is 18 years..
- Pregnancy Exclusion
- Pregnancy.
- Vulnerable Population
- No vulnerable population selected. Informed consent is required and 'Lack of informed consent' is listed as an exclusion criterion. Subject information and informed consent documents are provided (including a version for legal representative), indicating that consent may be obtained from a legal representative where applicable; no paediatric assent is applicable because minimum age is 18 years.
Inclusion criteria
- {"criterion_text":"- Age equal to or greater than 18 years\n- Mechanically ventilated patients in whom a minimum mechanical ventilation time of 48 hours from randomization is expected.\n- Patients in whom it is necessary to maintain a RASS between -3 and -5."}
Exclusion criteria
- {"criterion_text":"- Contraindication for isoflurane or propofol.\n- Acute neurological pathology (head trauma, intraparenchymal hemorrhage, subarachnoid hemorrhage or post-operative neurosurgery).\n- Any type of disorder (blindness, deafness, dementia) or language barrier that prevents the completion of the scales for the assessment of delirium or cognitive assessment.\n- Life expectancy of less than 48 hours or patients with such a level of severity that death during admission to the ICU is considered highly probable.\n- Patients in whom repeated surgical interventions are expected during their stay in the ICU.\n- Patients with extracorporeal oxygenation system (ECMO).\n- Mandatory need for active humidification.\n- Need for benzodiazepine use due to a specific indication (e.g., withdrawal syndrome).\n- Neuromuscular disease or high spinal cord injury that may prevent weaning from mechanical ventilation due to baseline condition.\n- Mandatory need for active humidification.\n- Patients with extracorporeal CO2 extraction system (ECCO2R).\n- Critical burn patients.\n- Patients admitted due to recovered cardiorespiratory arrest.\n- History of ventricular tachycardia/long QT syndrome.\n- Patients who have remained on mechanical ventilation for more than 48 hours at the time of randomization.\n- Tidal volume less than 300 ml or PaCO2 greater than 50 mm Hg at the time of randomization.\n- Pregnancy.\n- History of allergy or intolerance to isoflurane."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean number of days free of mechanical ventilation at day 28 from randomization.","definition_or_measurement_approach":"Measured as mean number of days free of mechanical ventilation evaluated at day 28 from randomization."}
Secondary endpoints
- {"endpoint_text":"- Mean number of days free of ICU stay on day 28 from randomization.\n- Average number of hours until extubation after withdrawal of sedation evaluated on the day of withdrawal or on day 28, whichever occurs first, from randomization.\n- Average RASS scale score maintained during the sedation maintenance period by participants in both treatment arms.\n- Proportion of participants that require the addition one or more hypnotics.\n- Proportion of participants with delirium on day 28 and average number of days with delirium on day 28 (assessed using the CAM-ICU scale).\n- Proportion of participants who died from any cause until day 60 from randomization.\n- Proportion of participants with symptoms of anxiety, depression or post-traumatic stress disorder 90 days after hospital discharge.\n- Proportion of patients who present an abnormal score in the cognitive assessment 90 days after hospital discharge.\n- Proportion of patients presenting adverse reactions in both arms.\n- Average number of hours to awakening (RASS range from -1 to +1) after sedation withdrawal.\n- Proportion of patients with abnormal scores on functional activity assessment (Barthel Index) at 90 days after hospital discharge.","definition_or_measurement_approach":"Endpoints are defined in the protocol: ICU- and ventilation-free days counted to day 28; extubation and awakening times measured in hours; delirium assessed using CAM-ICU; RASS scores for sedation level; mortality assessed to day 60; cognitive and functional assessments at 90 days post-discharge; proportion measures are event counts/denominators as defined in protocol."}
Recruitment
- Planned Sample Size
- 620
- Recruitment Window Months
- 31
- Consent Approach
- Informed consent is required; 'Lack of informed consent' is an exclusion. Subject information and informed consent forms are provided (including a legal representative version), indicating consent may be obtained from a legal representative for patients unable to consent. Minimum age is 18 so no assent procedures for minors are applicable. Documents appear to be provided in Spanish (translations appear for other trial texts).
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 620
Spain
- Earliest CTIS Part Ii Submission Date
- 10-02-2025
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 382
- Number Of Sites
- 28
- Number Of Participants
- 620
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Aris Pérez Lucendo
- Principal Investigator Email
- aris.perezlucendo@gmail.com
- Contact Person Name
- Aris Pérez Lucendo
- Contact Person Email
- aris.perezlucendo@gmail.com
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Mónica García Simón
- Principal Investigator Email
- mgs11122002@yahoo.es
- Contact Person Name
- Mónica García Simón
- Contact Person Email
- mgs11122002@yahoo.es
- Site Name
- Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Jesús Caballero López
- Principal Investigator Email
- jcaballero.lleida.ics@gencat.cat
- Contact Person Name
- Jesús Caballero López
- Contact Person Email
- jcaballero.lleida.ics@gencat.cat
- Site Name
- Hospital Doctor Jose Molina Orosa
- Department Name
- Intensive medicine
- Principal Investigator Name
- Andoni García Muñoz
- Principal Investigator Email
- andogarcia90@hotmail.com
- Contact Person Name
- Andoni García Muñoz
- Contact Person Email
- andogarcia90@hotmail.com
- Site Name
- Hospital General Universitario Santa Lucia
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Agueda Ojados Muñoz
- Principal Investigator Email
- aguedaojados@gmail.com
- Contact Person Name
- Agueda Ojados Muñoz
- Contact Person Email
- aguedaojados@gmail.com
- Site Name
- Hospital Universitario Rio Hortega
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Ana María Prieto de Lamo
- Principal Investigator Email
- amprietolamo@gmail.com
- Contact Person Name
- Ana María Prieto de Lamo
- Contact Person Email
- amprietolamo@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Eva Benveniste Pérez
- Principal Investigator Email
- evabenve@gmail.com
- Contact Person Name
- Eva Benveniste Pérez
- Contact Person Email
- evabenve@gmail.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Miguel Angel Romera
- Principal Investigator Email
- miguelangel.romera@salud.madrid.org
- Contact Person Name
- Miguel Angel Romera
- Contact Person Email
- miguelangel.romera@salud.madrid.org
- Site Name
- Hospital Universitario Reina Sofía de Murcia
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Julián Triviño Hidalgo
- Principal Investigator Email
- julian.trivino.hidalgo@gmail.com
- Contact Person Name
- Julián Triviño Hidalgo
- Contact Person Email
- julian.trivino.hidalgo@gmail.com
- Site Name
- Hospital Universitario De Getafe
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Carmen Rodríguez Solís
- Principal Investigator Email
- carmenrguezsolis@gmail.com
- Contact Person Name
- Carmen Rodríguez Solís
- Contact Person Email
- carmenrguezsolis@gmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Intensive Medicine
- Principal Investigator Name
- José Manuel Gómez García
- Principal Investigator Email
- semagomezgarcia@hotmail.com
- Contact Person Name
- José Manuel Gómez García
- Contact Person Email
- semagomezgarcia@hotmail.com
- Site Name
- Hospital Vega Baja De Orihuela
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Carola Gimenez-Esparza Vich
- Principal Investigator Email
- carolagimenezesparzavich@gmail.com
- Contact Person Name
- Carola Gimenez-Esparza Vich
- Contact Person Email
- carolagimenezesparzavich@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Intensive medicine
- Principal Investigator Name
- José Antonio Márquez Alonso
- Principal Investigator Email
- joseantoniomarquezalonso@gmail.com
- Contact Person Name
- José Antonio Márquez Alonso
- Contact Person Email
- joseantoniomarquezalonso@gmail.com
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Mario Dalorzo González
- Principal Investigator Email
- mardago31@gmail.com
- Contact Person Name
- Mario Dalorzo González
- Contact Person Email
- mardago31@gmail.com
- Site Name
- Hospital General Universitario De Albacete
- Department Name
- Intensive medicine
- Principal Investigator Name
- Jose Manuel Gutierrez Rubio
- Principal Investigator Email
- gutoman67@gmail.com
- Contact Person Name
- Jose Manuel Gutierrez Rubio
- Contact Person Email
- gutoman67@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Ana María del Saz Ortiz
- Principal Investigator Email
- amdelsaz@gmail.com
- Contact Person Name
- Ana María del Saz Ortiz
- Contact Person Email
- amdelsaz@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Intensive medicine
- Principal Investigator Name
- José Manuel Añón Elizalde
- Principal Investigator Email
- josem.anon@salud.madrid.org
- Contact Person Name
- José Manuel Añón Elizalde
- Contact Person Email
- josem.anon@salud.madrid.org
- Site Name
- Hospital Universitario De Fuenlabrada
- Department Name
- Intensive medicine
- Principal Investigator Name
- Carolina Sena Pérez
- Principal Investigator Email
- carmencarolina.sena@salud.madrid.org
- Contact Person Name
- Carolina Sena Pérez
- Contact Person Email
- carmencarolina.sena@salud.madrid.org
- Site Name
- Hospital Galdakao-Usansolo Ospitalea
- Department Name
- Intensive medicine
- Principal Investigator Name
- Iraia Arbelaiz Beltrán
- Principal Investigator Email
- cta.ucicec@gmail.com
- Contact Person Name
- Iraia Arbelaiz Beltrán
- Contact Person Email
- cta.ucicec@gmail.com
- Site Name
- Hospital Universitario Rey Juan Carlos
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Manuel Pérez Torres
- Principal Investigator Email
- manuel.ptorres@hospitalreyjuancarlos.es
- Contact Person Name
- Manuel Pérez Torres
- Contact Person Email
- manuel.ptorres@hospitalreyjuancarlos.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Paola Cárdenas Campos
- Principal Investigator Email
- pcardenas@bellvitgehospital.cat
- Contact Person Name
- Paola Cárdenas Campos
- Contact Person Email
- pcardenas@bellvitgehospital.cat
- Site Name
- Hospital Santa María
- Department Name
- Intensive medicine
- Principal Investigator Name
- Jesús Caballero López
- Principal Investigator Email
- cta.ucicec@gmail.com
- Contact Person Name
- Jesús Caballero López
- Contact Person Email
- cta.ucicec@gmail.com
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Mª Paz Escuela Gericó
- Principal Investigator Email
- mpescuela@gmail.com
- Contact Person Name
- Mª Paz Escuela Gericó
- Contact Person Email
- mpescuela@gmail.com
- Site Name
- Hospital Universitario de Jaén
- Department Name
- Intensive medicine
- Principal Investigator Name
- Miguel Angel Fernandez Sacristán
- Principal Investigator Email
- cta.ucicec@gmail.com
- Contact Person Name
- Miguel Angel Fernandez Sacristán
- Contact Person Email
- cta.ucicec@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Sofía Contreras Medina
- Principal Investigator Email
- raquelsofia.contreras@vallhebron.cat
- Contact Person Name
- Sofía Contreras Medina
- Contact Person Email
- raquelsofia.contreras@vallhebron.cat
- Site Name
- Hospital Regional Universitario de Málaga
- Department Name
- Intensive medicine
- Principal Investigator Name
- Guillermo Gómez
- Principal Investigator Email
- guigoga1286@gmail.com
- Contact Person Name
- Guillermo Gómez
- Contact Person Email
- guigoga1286@gmail.com
- Site Name
- Hospital Universitari Joan XXIII De Tarragona
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Oriol Plans Galván
- Principal Investigator Email
- oplans.hj23.ics@gencat.cat
- Contact Person Name
- Oriol Plans Galván
- Contact Person Email
- oplans.hj23.ics@gencat.cat
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Intensive Medicine
- Principal Investigator Name
- Manel Santafe Colomina
- Principal Investigator Email
- santafe.manel@gmail.com
- Contact Person Name
- Manel Santafe Colomina
- Contact Person Email
- santafe.manel@gmail.com
Sponsor
Primary sponsor
- Full Name
- Hospital Universitario La Paz
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Sedaconda 100% líquido para inhalación del vapor
- Active Substance
- Isoflurane
- Modality
- Small molecule
- Routes Of Administration
- Inhalation
- Route
- Inhalation
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- Max daily 336 ml
- Investigational Product Name
- Propofol Fresenius 20 mg/ml emulsion for injection/infusion
- Active Substance
- Propofol
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- Max daily 96 mg/kg
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