Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions (DEXA-REFINE)

February 16, 2024 updated by: Jesus Villar, Dr. Negrin University Hospital

Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)

Background: There are no proven therapies specific for pulmonary dysfunction in patients with acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of corticosteroids in AHRF and ARDS caused by infections remains controversial.

Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing dexamethasone in mechanically ventilated adult patients with established AHRF (including ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x 10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days at 28 days. All analyses will be done according to the intention-to-treat principle.

Study Overview

Status

Recruiting

Conditions

Acute Hypoxemic Respiratory Failure

Intervention / Treatment

Drug: Dexamethasone

Detailed Description

Acute hypoxemic respiratory failure (AHRF), and its more severe form termed the acute respiratory distress syndrome (ARDS), is a catastrophic illness of multifactorial etiology characterized by a severe inflammatory process of the lung leading to hypoxemic respiratory failure requiring mechanical ventilation (MV). Pulmonary infections are the leading causes of AHRF and ARDS. Translational research has established a strong association between dysregulated systemic and pulmonary inflammation and progression or delayed resolution of AHRF.2 Glucocorticoid receptor-mediated downregulation of systemic and pulmonary inflammation is essential to accelerate disease resolution and restore tissue homeostasis, and can be enhanced with glucocorticoid treatment.

The COVID-19 pandemic is a critical moment for the world, in which even industrially advanced countries have rapidly reached intensive care units (ICUs) saturation, and intensivists are forced to make difficult ethical decisions that are uncommon outside war zones. As with other bacterial or viral infections, severe pneumonia is the main condition leading to AHRF and ARDS requiring weeks of MV with high mortality (35-55%) in critically ill patients. There has been great interest in the role of corticosteroids to attenuate the pulmonary and systemic damage in ARDS patients because of their potent anti-inflammatory and antifibrotic properties.3 Corticosteroids have been off patent for greater than 20 years, they are cheap, and globally equitable. However, the efficacy of corticosteroids in AHRF (including ARDS) caused by infections remains controversial.

Only two large randomized clinical trials (RCT) have shown that the administration of dexamethasone is able to reduce mortality in patients with AHRF. Villar et al in Spain observed that moderate doses of dexamethasone (10-20 mg/d x 10 days) caused a 15% absolute reduction of 60-day mortality in patients with established moderate-to-severe ARDS from multiple etiologies. Horby et al in the RECOVERY trial in Great Britain reported that dexamethasone at low doses (6 mg/d x 10 days) reduced 28-day mortality in patients with AHRF caused by COVID-19. These findings confirmed that corticosteroid therapy is associated with a sizable reduction in duration of MV and hospital mortality. These two RCTs will change clinical practice for the management of AHRF and ARDS. However, there is a reasonable doubt whether dexamethasone at moderate doses (10-20 mg/d) would cause a greater reduction in mortality than 6 mg/d. Our goal in this study is to respond this question.

Study Type

Interventional

Enrollment (Estimated)

980

Phase

Phase 4

Contacts and Locations

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

Study Contact

Name: Jesús Villar, MD
Phone Number: +34606860027
Email: jesus.villar54@gmail.com

Study Contact Backup

Name: Arthur Slutsky, MD
Phone Number: +14168244000
Email: Arthur.Slutsky@unityhealth.to

Study Locations

Spain
- - Albacete, Spain, 02006
    - Not yet recruiting
    - Complejo Hospitalario Universitario de Albacete (ICU)
    - Contact:
      
      Isabel Murcia, MD
      
      Phone Number: +34609212303
      
      Email: murciasaez.im@gmail.com
    - Contact:
      
      Ángela Prado-Mira, MD
      
      Phone Number: +34616624188
      
      Email: angge.86@gmail.com
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clinic de Barcelona (AVI)
    - Contact:
      
      Pedro Castro, MD
      
      Phone Number: +34645378213
      
      Email: PCASTRO@clinic.cat
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clinic de Barcelona (Cardiac ICU)
    - Contact:
      
      Manuel Castallá
      
      Phone Number: +34696605769
      
      Email: MCASTE@clinic.cat
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clínic (Hepatic ICU)
    - Contact:
      
      Javier Fernández, MD
      
      Phone Number: +34652421887
      
      Email: JFDEZ@clinic.cat
    - Contact:
      
      María Hernández, MD
      
      Phone Number: +34636123288
      
      Email: mhernandezt@clinic.cat
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clínic de Barcelona (Anesthesia)
    - Contact:
      
      Carlos Ferrando, MD
      
      Phone Number: +34659583815
      
      Email: cafeoranestesia@gmail.com
    - Contact:
      
      Ricard Mellado-Artigas, MD
      
      Phone Number: +34646217716
      
      Email: rmartigas@gmail.com
  - Ciudad Real, Spain, 13005
    - Not yet recruiting
    - Hospital General de Ciudad Real (ICU)
    - Contact:
      
      Alfonso Ambrós, MD
      
      Phone Number: +34696544641
      
      Email: alfonsoa@sescam.jccm.es
    - Contact:
      
      Carmen Martín, MD
      
      Phone Number: +34639931571
      
      Email: mcarmartin@hotmail.com
  - Cuenca, Spain, 16002
    - Not yet recruiting
    - Hospital Virgen de la Luz (ICU)
    - Contact:
      
      Elena González, MD
      
      Phone Number: +34669900472
      
      Email: elena03gon@gmail.com
    - Contact:
      
      Rosario Solano, MD
      
      Phone Number: +34636257419
      
      Email: charosolve@hotmail.com
  - La Coruña, Spain, 15006
    - Not yet recruiting
    - Hospital Universitario de A Coruña (ICU)
    - Contact:
      
      Fernando Mosteiro, MD
      
      Phone Number: +346002645008
      
      Email: fernando.mosteiro.pereira@sergas.es
    - Contact:
      
      Lidia Pita-García, MD
      
      Phone Number: +34615459500
      
      Email: lidia.pita.garcía@sergas.es
  - León, Spain, 24001
    - Not yet recruiting
    - Complejo Asistencial Universitario de León (ICU)
    - Contact:
      
      Demetrio Carriedo, MD
      
      Phone Number: +34669342578
      
      Email: dcarriedo@saludcastillayleon.es
    - Contact:
      
      Francisco J Díaz, MD
      
      Phone Number: +34679195052
      
      Email: fjdmowi@hotmail.com
  - Madrid, Spain, 28006
    - Not yet recruiting
    - Hospital Universitario La Princesa (ICU)
    - Contact:
      
      Fernando Suarez-Sipmann, MD
      
      Phone Number: +34669792961
      
      Email: fsuarezsipmann@gmail.com
  - Madrid, Spain, 28034
    - Not yet recruiting
    - Hospital Universitario Ramón y Cajal (Anesthesia)
    - Contact:
      
      David Pestaña, MD
      
      Phone Number: +34609353414
      
      Email: dpestanalag@hotmail.com
    - Contact:
      
      Angel Candela, MD
      
      Email: acandela.hrc@salud.madrid.org
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Clínico Universitario San Carlos (ICU)
    - Contact:
      
      Paloma González-Arenas, MD
      
      Phone Number: +34670576645
      
      Email: pgarenas@gmail.com
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Universitario Fundación Jiménez Díaz (ICU)
    - Contact:
      
      Anxela Vidal, MD
      
      Phone Number: +34680713669
      
      Email: anxelavidal@gmail.com
    - Contact:
      
      César Calvo, MD
      
      Phone Number: +34618100522
      
      Email: Cperez@fjd.es
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Hospital Universitario Doce de Octubre (ICU)
    - Contact:
      
      Mario Chico, MD
      
      Phone Number: +34679328904
      
      Email: murgchico@yahoo.es
    - Contact:
      
      MD
  - Madrid, Spain, 28046
    - Not yet recruiting
    - Hospital Universitario La Paz (Anesthesia)
    - Contact:
      
      Emilio Maseda, MD
      
      Phone Number: +34629018689
      
      Email: emilio.maseda@gmail.com
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz (ICU)
    - Contact:
      
      José M Añón, MD
      
      Phone Number: +34620152794
      
      Email: jesus.villar54@gmail.com
    - Contact:
      
      Juan C Figueira, MD
      
      Phone Number: +34619182014
      
      Email: luarnaria@yahoo.es
  - Murcia, Spain, 30120
    - Not yet recruiting
    - Hospital Universitario Virgen de Arrixaca (Anesthesia)
    - Contact:
      
      Carlos García-Palenciano, MD
      
      Phone Number: +34629721053
      
      Email: carlos.garciapalenciano@gmail.com
    - Contact:
      
      Piedad Martinez-Gil, MD
      
      Phone Number: +34615067008
      
      Email: pimagil@hotmail.com
  - Murcia, Spain, 30120
    - Not yet recruiting
    - Hospital Universitario Virgen de Arrixaca (ICU)
    - Contact:
      
      Domingo Martínez, MD
      
      Phone Number: +34670334050
      
      Email: dmbct1@gmail.com
    - Contact:
      
      Juan A Soler, MD
      
      Phone Number: +34661764387
      
      Email: juasobar@hotmail.com
  - Málaga, Spain, 29010
    - Not yet recruiting
    - Hospital Universitario Regional de Malaga Carlos Haya (ICU)
    - Contact:
      
      Juan M Mora-Ordoñez, MD
      
      Phone Number: +34666940647
      
      Email: jumouci@gmail.com
  - Pamplona, Spain, 31008
    - Not yet recruiting
    - Clinica Universidad de Navarra
    - Contact:
      
      Pablo Monedero, MD
      
      Phone Number: +34685561229
      
      Email: pmonedero@unav.es
  - Pontevedra, Spain, 36071
    - Not yet recruiting
    - Hospital Universitario Montecelo (Anesthesia)
    - Contact:
      
      Marina Varela, MD
      
      Phone Number: +34607358008
      
      Email: marina.varela.duran@sergas.es
    - Contact:
      
      Pilar Diaz-Parada, MD
      
      Phone Number: +34686101085
      
      Email: pilar.diaz.parada@sergas.es
  - Santa Cruz De Tenerife, Spain, 38010
    - Not yet recruiting
    - Hospital Universitario Nuestra Señora de Candelaria (ICU)
    - Contact:
      
      Raquel Montiel, MD
      
      Phone Number: +34617749631
      
      Email: raquelmontiel@gmail.com
    - Contact:
      
      Dacil Parrilla, MD
      
      Phone Number: +34600559881
      
      Email: gudru74@yahoo.es
  - Segovia, Spain, 40002
    - Not yet recruiting
    - Hospital General de Segovia (ICU)
    - Contact:
      
      Alec Tallet, MD
      
      Phone Number: +34679327648
      
      Email: alectaes@me.com
  - Valencia, Spain, 46010
    - Not yet recruiting
    - Hospital Clinico Universitario de Valencia (Anesthesia)
    - Contact:
      
      Gerardo Aguilar, MD
      
      Phone Number: +34639715165
      
      Email: gaguilar.aguilar1@gmail.com
    - Contact:
      
      José A Carbonell, MD
      
      Phone Number: +34605472557
      
      Email: joseacarbonell19@gmail.com
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia (ICU)
    - Contact:
      
      José Ferreres, MD
      
      Phone Number: +34627557288
      
      Email: ferreresj@gmail.com
    - Contact:
      
      María L Blasco, MD
      
      Phone Number: +34609231344
      
      Email: mablas13@gmail.com
  - Valladolid, Spain, 47003
    - Not yet recruiting
    - Hospital Clínico Universitario de Valladolid (Anesthesia)
    - Contact:
      
      José I Gómez-Herreras, MD
      
      Phone Number: +34693417969
      
      Email: jgomez012001@yahoo.es
    - Contact:
      
      Mario Lorenzo-López, MD
      
      Phone Number: +34654860101
      
      Email: mariolorenzo17@yahoo.es
  - Valladolid, Spain, 47012
    - Not yet recruiting
    - Hospital Universitario Río Hortega (Anesthesia)
    - Contact:
      
      César Aldecoa, MD
      
      Phone Number: +34657500031
      
      Email: cesar.aldecoa@gmail.com
    - Contact:
      
      Jesús Rico, MD
      
      Phone Number: +34609024076
      
      Email: jricofe@saludcastillayleon.es
  - Valladolid, Spain, 47012
    - Recruiting
    - Hospital Universitario Río Hortega (ICU)
    - Contact:
      
      Lorena Fernández, MD
      
      Phone Number: +34626479670
      
      Email: mlfernandezrod@saludcastillayleon.es
    - Contact:
      
      Pablo Blanco-Schweizer, MD
      
      Phone Number: +34686892299
      
      Email: pblancosc@saludcastillayleon.es
  - Zamora, Spain, 49022
    - Not yet recruiting
    - Hospital Virgen de la Concha (ICU)
    - Contact:
      
      Concepción Tarancón, MD
      
      Phone Number: +34609591652
      
      Email: fcontama@yahoo.es
    - Contact:
      
      Silvia Cortés-Díaz, MD
      
      Phone Number: +34616290921
      
      Email: silviamcortesdiaz@hotmail.com
- Barcelona
  - Terrassa, Barcelona, Spain, 08221
    - Not yet recruiting
    - Hospital Universitario Mutua Terrassa (ICU)
    - Contact:
      
      María M Fernández, MD
      
      Phone Number: +34654027970
      
      Email: marufaes@yahoo.es
    - Contact:
      
      Josep Trenado, MD
      
      Phone Number: +34630158583
      
      Email: jtrenado@mutuaterrassa.es
- Ciudad Real
  - Alcazar de San Juan, Ciudad Real, Spain, 13600
    - Not yet recruiting
    - Hospital General La Mancha Centro (ICU)
    - Contact:
      
      Carmen Martin-Delgado, MD
      
      Phone Number: +34628024856
      
      Email: carmenmartind35@gmail.com
- La Coruña
  - Santiago De Compostela, La Coruña, Spain, 15706
    - Not yet recruiting
    - Complejo Hospitalario Universitario de Santiago (Anesthesia)
    - Contact:
      
      Julián Álvarez, MD
      
      Phone Number: +34606360187
      
      Email: julian.alvarez.escudero@sergas.es
    - Contact:
      
      Agustín Cariñena, MD
      
      Email: agustincarinena@gmail.com
- León
  - Ponferrada, León, Spain, 24404
    - Not yet recruiting
    - Hospital General El Bierzo (ICU)
    - Contact:
      
      Eleuterio Merayo, MD
      
      Phone Number: +34619906005
      
      Email: emerayom@gmail.com
    - Contact:
      
      Chanel Martínez, MD
      
      Phone Number: +34630042686
      
      Email: chanel.mrtnz@gmail.com
- Madrid
  - Coslada, Madrid, Spain, 28822
    - Not yet recruiting
    - Hospital Universitario del Henares (ICU)
    - Contact:
      
      Federico Gordo, MD
      
      Phone Number: +34630373288
      
      Email: fgordo5@gmail.com
  - Getafe, Madrid, Spain, 28905
    - Not yet recruiting
    - Hospital Universitario de Getafe (ICU)
    - Contact:
      
      José A Lorente, MD
      
      Phone Number: +34649196626
      
      Email: joseangel.lorente@salud.madrid.org
    - Contact:
      
      Raquel Herrero, MD
      
      Email: raquelher@hotmail.com
  - Leganés, Madrid, Spain, 28911
    - Not yet recruiting
    - Hospital Universitario Severo Ochoa (ICU)
    - Contact:
      
      Trinidad Puente, MD
      
      Phone Number: +34699883428
      
      Email: tpuente_12@hotmail.com
  - Majadahonda, Madrid, Spain, 28222
    - Not yet recruiting
    - Hospital Universitario Puerta de Hierro (ICU)
    - Contact:
      
      Miguel A Romera, MD
      
      Phone Number: +34639420622
      
      Email: miguelangel.romera@gmail.com
    - Contact:
      
      Miguel Valdivia, MD
      
      Email: valdivia1976@gmail.com
- Toledo
  - Talavera De La Reina, Toledo, Spain, 45600
    - Not yet recruiting
    - Hospital Nuestra Señora del Prado (ICU)
    - Contact:
      
      Francisco Alba, MD
      
      Phone Number: +34687823357
      
      Email: pacoalbagarcia@hotmail.com
    - Contact:
      
      Vega Losada, MD
      
      Phone Number: +34679982018
      
      Email: vegalosada@hotmail.com
- Vizcaya
  - Barakaldo, Vizcaya, Spain, 48903
    - Not yet recruiting
    - Hospital Universitario de Cruces (Anesthesia)
    - Contact:
      
      Gonzalo Tamayo, MD
      
      Phone Number: +34655740637
      
      Email: gonzalotamayo@gmail.com
    - Contact:
      
      Alberto Martínez-Ruiz, MD
      
      Phone Number: +34610494664
      
      Email: alberto.martinezruiz@osakidetza.eus
  - Barakaldo, Vizcaya, Spain, 48903
    - Not yet recruiting
    - Hospital Universitario de Cruces (ICU)
    - Contact:
      
      Tomás Muñoz, MD
      
      Phone Number: +34619576429
      
      Email: tomas.munozmartinez@osakidetza.net
    - Contact:
      
      Pablo Serna-Grande, MD
      
      Phone Number: +34620686825
      
      Email: pablo.serna.grande@gmail.com

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

Description

Inclusion Criteria:

age 18 years or older;
intubated and mechanically ventilated;
acute onset of AHRF (as defined by a PaO2/FiO2 ≤300 mmHg during at least 6 hours from diagnosis. For the measurement of PaO2 and calculation of PaO2/FiO2 ratio, the minimum accepted value for PEEP is 5 cmH2O and for FiO2 is 0.3. ARDS is defined by Berlin criteria,4 which includes: (i) having pneumonia or worsening respiratory symptoms, (ii) bilateral pulmonary infiltrates on chest imaging (x-ray or CT scan), (iii) absence of left atrial hypertension or no clinical signs of left heart failure, and (iv) hypoxemia, as defined by a PaO2/FiO2 ≤300 mmHg on positive end-expiratory pressure (PEEP) of ≥5 cmH2O, regardless of FiO2.
Pulmonary or systemic infectious etiology of AHRF.

Exclusion Criteria:

Patients with a known contraindication to corticosteroids,
Patient included in another therapeutic clinical trial
Lack of informed consent

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

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone (low dose) Dexamethasone: 6 mg/iv/day during 10 days.	Drug: Dexamethasone Intravenous dexamethasone (low vs. moderate doses) during 10 days Other Names: Decadron Dexasone Diodex
Active Comparator: Dexamethasone (moderate dose) Dexamethasone: 20 mg/iv/ daily from day of randomization (day 1) during 5 days, followed by 10 mg/iv/ daily from Day 6 to Day 10 of randomization.	Drug: Dexamethasone Intravenous dexamethasone (low vs. moderate doses) during 10 days Other Names: Decadron Dexasone Diodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60-day mortality Time Frame: 60 days	All-cause mortality at 60 days after randomization	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator-free days Time Frame: 28 days	Number of ventilator-free days (VFDs) at Day 28 (defined as days being alive and free from mechanical ventilation at day 28 after randomization. For patients ventilated 28 days or longer and for subjects who die, VFD is 0.	28 days

Collaborators and Investigators

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

Sponsor

Dr. Negrin University Hospital

Collaborators

Li Ka Shing Knowledge Institute

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Investigators

Principal Investigator: Jesús Villar, MD, Hospital Universitario Dr. Negrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 6, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

September 5, 2020

First Submitted That Met QC Criteria

September 5, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ICI20-00062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Acute Hypoxemic Respiratory Failure

Beijing Chao Yang Hospital

Recruiting

Wean Early With HFNCO vs NPPV in Patients With AHRF

Patients With Acute Hypoxemic Respiratory Failure

China
Dr. Behcet Uz Children's Hospital

Completed

Comparing Closed-loop FiO2 Controller With Conventional Control of FiO2

Acute Respiratory Failure | Acute Hypoxemic Respiratory Failure | Acute Hypoxemic and Hypercapnic Respiratory Failure

Turkey
Yonsei University

Not yet recruiting

Optimal Timing and Failure Prediction of High Flow Nasal Cannula Oxygen Therapy in Emergency Department: Prospective Observational Single Center Study

Respiratory Failure | Respiratory Insufficiency | Hypercapnic Respiratory Failure | Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure | Ventilatory Depression | Hypoxemic Respiratory Failure | Respiratory Depression | Hypoxemic Acute Respiratory Failure | Hypercapnic Acute

Korea, Republic of
Hospital General Universitario Morales Meseguer

Not yet recruiting

Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy (ProPNIVFlow)

Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
Niguarda Hospital

Recruiting

Non-invasive Ventilation Versus High Flow Oxygen (HFO)

Pneumonia-associated Acute Hypoxemic Respiratory Failure

Italy
Poitiers University Hospital

Recruiting

Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure (SOHO)

Acute Respiratory Failure | Hypoxemic Respiratory Failure

France
Nantes University Hospital

Completed

High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery (Optiflow)

Hypoxemic Acute Respiratory Failure

France
Sunnybrook Health Sciences Centre

Recruiting

HNFO With or Without Helmet NIV for Oxygenation Support in Acute Respiratory Failure Pilot RCT (HONOUR)

Acute Hypoxemic Respiratory Failure

Canada
Siriraj Hospital

Recruiting

Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure

Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure

Thailand
Fisher and Paykel Healthcare
Centre hospitalier de l'Université de Montréal (CHUM); Institut universitaire...

Not yet recruiting

Pilot Physiological Evaluation of an Investigational Mask With Expiratory Washout.

Acute Hypoxemic Respiratory Failure | Acute Hypercapnic Respiratory Failure

Clinical Trials on Dexamethasone

Ottawa Hospital Research Institute

Completed

Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for TAPS in Breast Cancer Patients (REaCT-TAPS)

Pain Syndrome | Early-stage Breast Cancer

Canada
Centre hospitalier de l'Université de Montréal...

Completed

Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study (DEXEL-RH)

Prevention of Hypersensitivity Reactions to Paclitaxel

Canada
Shanghai Jiao Tong University Affiliated Sixth...

Completed

Low-dose Intravenous Dexamethasone at Different Times as Adjunvants for Brachial Plexus Blocks

Analgesia | Time | Brachial Plexus Block | Shoulder Surgery | Dexamethasone | Intravenous Drug Usage

China
Universidade Federal de Pernambuco

Completed

Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial (EDRMT)

Diabetic Macular Edema

Brazil
Vanderbilt University Medical Center

Terminated

Comparison of Dexamethasone Oral Preparations to Assess Taste and Acceptance in Children With Asthma and Croup

Asthma | Croup

United States
Dr. Stephen Choi
The Physicians' Services Incorporated Foundation

Completed

The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block (ISB-Dex)

Shoulder Surgery | Nerve Block

Canada
Poznan University of Medical Sciences

Recruiting

Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Wrist Injuries | Hand Injuries | Hand Injuries and Disorders | Hand Disease | Wrist Disease

Poland
University of California, San Francisco

Completed

Dexamethasone Solution and Dexamethasone in Mucolox™

Oral Lichen Planus | Pemphigus Vulgaris | Mucous Membrane Pemphigoid | Chronic Graft-versus-host-disease

United States
Universitätsklinikum Hamburg-Eppendorf
Gemeinsamer Bundesausschuss (G-BA); Staburo GmbH

Recruiting

Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy (AlloRelapseMM)

Multiple Myeloma

Germany
University of Belgrade

Completed

Dexamethasone in Lower Third Molar Surgery

Impacted Third Molar Tooth

Serbia

Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions (DEXA-REFINE)

Efficacy of Higher vs. Lower Doses of Dexamethasone in Patients With Acute Hypoxemic Respiratory Failure (Including ARDS) Caused by Infections (Including COVID-19)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Acute Hypoxemic Respiratory Failure

Clinical Trials on Dexamethasone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations