Extracorporeal Circulation; ComplicationsNCT05948332
Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
An observational study of Extracorporeal Circulation; Complications and Extracorporeal Membrane Oxygenation Complication, run by Prashant Nasa at 1 site in United Arab Emirates.
Trial summary
The aim of this study is to identify existing definitions and therapeutic approaches for acute right ventricular injury (RVI) in patients receiving extracorporeal membrane oxygenation (ECMO) for respiratory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication, Right Heart Failure
- What is being tested?
- Delphi Rounds to generate consensus opinions among Experts
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare professionals involved in the management adult patients receiving Extracorporeal Membrane Oxygenation.
Who may be able to join
- Working in an active Extracorporeal Life Support Organisation (ELSO) member centre for > 5 years, or clinical experience in cardiorespiratory failure for > 5 years.
- Original research in the field of ECMO or Cardiorespiratory failure (at least one peer-reviewed publication as a leading author).
Who cannot join
- People who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
NMC Specialty Hospital, Al Nahda
Dubai
About this study
Official title: Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation for Respiratory Support Using the Delphi Method: A PRORVnet - Expert Consensus Statements
The aim of this study is to identify existing definitions and therapeutic approaches for acute right ventricular injury (RVI) in patients receiving extracorporeal membrane oxygenation (ECMO) for respiratory support. The objective of the study is to generate expert consensus statements on the definition and management of acute RVI in this high-risk patient population, using a Delphi method. The standardised RVI definition during ECMO for respiratory support and a consensus-based management approach to RVI will facilitate systematic aggregation of data across clinical trials to harmonise patient selection and compare therapeutic interventions.
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) is increasingly being used as part of the algorithm for the management of patients with respiratory failure in whom conventional ventilatory strategies have failed to preserve gas exchange without use of settings that may result in ventilator-induced lung injury. ECMO for respiratory support may be required in critically ill patients with any of the following types of respiratory failure: a) acute respiratory distress syndrome (ARDS) of any aetiology (infectious or non-infectious, pulmonary or extrapulmonary), defined according to the Berlin criteria of ARDS, or the more recently proposed Kigali modification and the New Global definition of ARDS; b) acute reversible hypoxemic and/or hypercapnic respiratory failure of any infectious or non-infectious aetiology (including pulmonary embolism and primary graft failure in lung transplantation recipients); and c) chronic hypoxemic and/or hypercapnic respiratory failure, as a bridge to lung transplantation strategy. Right ventricular injury (RVI) may develop in the context of any of the aforementioned types of respiratory failure and is characterised by a spectrum of abnormal RV biomechanics which all have been linked to mortality. One of the main mechanisms of RVI in patients with respiratory failure is pulmonary vasoconstriction caused by hypoxaemia and/or hypercapnic acidaemia leading to elevated RV afterload. Respiratory ECMO supports or replaces pulmonary gas exchange and theoretically may reverse the aforementioned mechanism of RVI and unloads the RV. However, RVI may persist or worsen despite application of ECMO and is strongly associated with significant mortality.
There is currently no universally accepted definition for RVI in patients receiving ECMO for respiratory support or evidence-based RV-targeted therapies. This may result in underdiagnosis of this clinical entity and clinical practice variations and hence there is a need to standardise diagnostic criteria as well as clarify therapeutic management. The objective of the current investigation is to generate consensus statements by experts on the definition and management of RVI in adult patients receiving ECMO for respiratory support, using a Delphi process.
The Delphi process is a well-known mechanism for generating consensus on a specific topic by tapping into the "collective intelligence" of the panel members. The Steering Committee members conduct iterative Delphi rounds to obtain an agreement among the Experts after completing a literature search on the currently available evidence and preparing the opening statements. The members of the Steering Committee will not take part in the Delphi surveys.
The investigators will be using a modified Delphi-based methodology involving global experts from different disciplines (intensive care medicine, anaesthesia, cardiac surgery, cardiology, or a combination of two or more specialties) who meet pre-specified qualification criteria. A survey will be sent to all potential panel members prior to commencement of the Delphi rounds, to ascertain expertise in the field. The entire study will be conducted through approximately three or four rounds of Google Forms-based Delphi questionnaires. The Experts will provide opinion on the problem areas; definition and management of acute RVI in patients receiving ECMO for respiratory support. The survey is organised into three domains: Definition, RVI severity, Management strategies, and Research Priorities. The problem areas, domains and statements were generated by systematic literature review. Most of these statements require a 7-point Likert scale rating or selecting appropriate options in multiple-choice questions (MCQs). In round one, there is an option to collect feedback from participating Experts in the offered open area, which will be evaluated before the round two questionnaire. Rounds are repeated until consensus (or stable dissensus) is reached (≥70% for the Likert scale and ≥80% for MCQs). Experts will be presented with the summary results of each round, and the survey procedure will be repeated with the amended questionnaire. The Delphi rounds will continue until the required consensus (or lack thereof) and statement stability is obtained.
- Conditions
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication, Right Heart Failure, Right Ventricular Dysfunction, Respiratory Failure, Respiratory Distress Syndrome
- Being tested
- Delphi Rounds to generate consensus opinions among Experts
- Keywords
- Extracorporeal Membrane Oxygenation, Heart Failure, Right Ventricular Injury, Respiratory Distress Syndrome
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Right, Respiratory Insufficiency, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi Rounds to generate consensus opinions among ExpertsBehavioural
The Investigators (Steering Committee) will select the experts from across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the definition and management of acute RVI in patients with receiving V-V ECMO, among the Experts. The selection criteria will be self-assessed through a survey among the potential Experts.
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus statements
Consensus amongst the expert panel regarding RVI definition and management will be achieved using Delphi method which includes iterative rounds of questions; Consensus will be considered reached when a statement achieves >80% of votes for multiple-choice questions and >70% for Likert-scale statements
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Sep 2023
- Primary completion26 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Circulation; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prashant Nasa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Vasileios Zochios, MRCP FFICM, Principal investigator, University Hospitals of Leicester NHS Trust, Glenfied Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948332
- Sponsor's protocol ID
- RVI_ECMO
- Status last verified
- Apr 2024
- First submitted
- 8 Jul 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be kept anonymous and be shared after the Delphi process during the publication.
Publications
Nasa P, Azoulay E, Chakrabarti A, Divatia JV, Jain R, Rodrigues C, Rosenthal VD, Alhazzani W, Arabi YM, Bakker J, Bassetti M, De Waele J, Dimopoulos G, Du B, Einav S, Evans L, Finfer S, Guerin C, Hammond NE, Jaber S, Kleinpell RM, Koh Y, Kollef M, Levy MM, Machado FR, Mancebo J, Martin-Loeches I, Mer M, Niederman MS, Pelosi P, Perner A, Peter JV, Phua J, Piquilloud L, Pletz MW, Rhodes A, Schultz MJ, Singer M, Timsit JF, Venkatesh B, Vincent JL, Welte T, Myatra SN. Infection control in the intensive care unit: expert consensus statements for SARS-CoV-2 using a Delphi method. Lancet Infect Dis. 2022 Mar;22(3):e74-e87. doi: 10.1016/S1473-3099(21)00626-5. Epub 2021 Nov 10.
PubMed 34774188Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.
PubMed 31408142Supady A, Combes A, Barbaro RP, Camporota L, Diaz R, Fan E, Giani M, Hodgson C, Hough CL, Karagiannidis C, Kochanek M, Rabie AA, Riera J, Slutsky AS, Brodie D. Respiratory indications for ECMO: focus on COVID-19. Intensive Care Med. 2022 Oct;48(10):1326-1337. doi: 10.1007/s00134-022-06815-w. Epub 2022 Aug 9.
PubMed 35945343ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
PubMed 37326646Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.
PubMed 26352116Matthay MA, Thompson BT, Ware LB. The Berlin definition of acute respiratory distress syndrome: should patients receiving high-flow nasal oxygen be included? Lancet Respir Med. 2021 Aug;9(8):933-936. doi: 10.1016/S2213-2600(21)00105-3. Epub 2021 Apr 27.
PubMed 33915103Sato R, Dugar S, Cheungpasitporn W, Schleicher M, Collier P, Vallabhajosyula S, Duggal A. The impact of right ventricular injury on the mortality in patients with acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care. 2021 May 21;25(1):172. doi: 10.1186/s13054-021-03591-9.
PubMed 34020703Zochios V, Yusuff H, Schmidt M; Protecting the Right Ventricle Network (PRORVnet). Acute right ventricular injury phenotyping in ARDS. Intensive Care Med. 2023 Jan;49(1):99-102. doi: 10.1007/s00134-022-06904-w. Epub 2022 Oct 11. No abstract available.
PubMed 36219228Huang S, Vignon P, Mekontso-Dessap A, Tran S, Prat G, Chew M, Balik M, Sanfilippo F, Banauch G, Clau-Terre F, Morelli A, De Backer D, Cholley B, Slama M, Charron C, Goudelin M, Bagate F, Bailly P, Blixt PJ, Masi P, Evrard B, Orde S, Mayo P, McLean AS, Vieillard-Baron A; ECHO-COVID research group. Echocardiography findings in COVID-19 patients admitted to intensive care units: a multi-national observational study (the ECHO-COVID study). Intensive Care Med. 2022 Jun;48(6):667-678. doi: 10.1007/s00134-022-06685-2. Epub 2022 Apr 21.
PubMed 35445822Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.
PubMed 29744563Vonk Noordegraaf A, Westerhof BE, Westerhof N. The Relationship Between the Right Ventricle and its Load in Pulmonary Hypertension. J Am Coll Cardiol. 2017 Jan 17;69(2):236-243. doi: 10.1016/j.jacc.2016.10.047.
PubMed 28081831Chad T, Yusuff H, Zochios V, Pettenuzzo T, Fan E, Schmidt M; Protecting the Right Ventricle network (PRORVnet). Right Ventricular Injury Increases Mortality in Patients With Acute Respiratory Distress Syndrome on Veno-Venous Extracorporeal Membrane Oxygenation: A Systematic Review and Meta-Analysis. ASAIO J. 2023 Jan 1;69(1):e14-e22. doi: 10.1097/MAT.0000000000001854. Epub 2022 Nov 13.
PubMed 36375040Dugar S, Sato R, Zochios V, Duggal A, Vallabhajosyula S; Protecting the Right Ventricle Network (PRORVnet). Defining Right Ventricular Dysfunction in Acute Respiratory Distress Syndrome. J Cardiothorac Vasc Anesth. 2022 Feb;36(2):632-634. doi: 10.1053/j.jvca.2021.09.001. Epub 2021 Sep 16. No abstract available.
PubMed 34583852Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: How to decide its appropriateness. World J Methodol. 2021 Jul 20;11(4):116-129. doi: 10.5662/wjm.v11.i4.116. eCollection 2021 Jul 20.
PubMed 34322364
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation for Respiratory Support Using the Delphi Method: A PRORVnet - Expert Consensus Statements
- ClinicalTrials.gov ID
- NCT05948332
- Acronym / sponsor ID
- RVI_ECMO
- Conditions
- Extracorporeal Circulation; Complications, Extracorporeal Membrane Oxygenation Complication, Right Heart Failure, Right Ventricular Dysfunction, Respiratory Failure, Respiratory Distress Syndrome
- Keywords
- Extracorporeal Membrane Oxygenation, Heart Failure, Right Ventricular Injury, Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Prashant NasaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify existing definitions and therapeutic approaches for acute right ventricular injury (RVI) in patients receiving extracorporeal membrane oxygenation (ECMO) for respiratory support. The objective of the study is to generate expert consensus statements on the definition and management of acute RVI in this high-risk patient population, using a Delphi method. The standardised RVI definition during ECMO for respiratory support and a consensus-based management approach to RVI will facilitate systematic aggregation of data across clinical trials to harmonise patient selection and compare therapeutic interventions.
Detailed description
Extracorporeal membrane oxygenation (ECMO) is increasingly being used as part of the algorithm for the management of patients with respiratory failure in whom conventional ventilatory strategies have failed to preserve gas exchange without use of settings that may result in ventilator-induced lung injury. ECMO for respiratory support may be required in critically ill patients with any of the following types of respiratory failure: a) acute respiratory distress syndrome (ARDS) of any aetiology (infectious or non-infectious, pulmonary or extrapulmonary), defined according to the Berlin criteria of ARDS, or the more recently proposed Kigali modification and the New Global definition of ARDS; b) acute reversible hypoxemic and/or hypercapnic respiratory failure of any infectious or non-infectious aetiology (including pulmonary embolism and primary graft failure in lung transplantation recipients); and c) chronic hypoxemic and/or hypercapnic respiratory failure, as a bridge to lung transplantation strategy. Right ventricular injury (RVI) may develop in the context of any of the aforementioned types of respiratory failure and is characterised by a spectrum of abnormal RV biomechanics which all have been linked to mortality. One of the main mechanisms of RVI in patients with respiratory failure is pulmonary vasoconstriction caused by hypoxaemia and/or hypercapnic acidaemia leading to elevated RV afterload. Respiratory ECMO supports or replaces pulmonary gas exchange and theoretically may reverse the aforementioned mechanism of RVI and unloads the RV. However, RVI may persist or worsen despite application of ECMO and is strongly associated with significant mortality.
There is currently no universally accepted definition for RVI in patients receiving ECMO for respiratory support or evidence-based RV-targeted therapies. This may result in underdiagnosis of this clinical entity and clinical practice variations and hence there is a need to standardise diagnostic criteria as well as clarify therapeutic management. The objective of the current investigation is to generate consensus statements by experts on the definition and management of RVI in adult patients receiving ECMO for respiratory support, using a Delphi process.
The Delphi process is a well-known mechanism for generating consensus on a specific topic by tapping into the "collective intelligence" of the panel members. The Steering Committee members conduct iterative Delphi rounds to obtain an agreement among the Experts after completing a literature search on the currently available evidence and preparing the opening statements. The members of the Steering Committee will not take part in the Delphi surveys.
The investigators will be using a modified Delphi-based methodology involving global experts from different disciplines (intensive care medicine, anaesthesia, cardiac surgery, cardiology, or a combination of two or more specialties) who meet pre-specified qualification criteria. A survey will be sent to all potential panel members prior to commencement of the Delphi rounds, to ascertain expertise in the field. The entire study will be conducted through approximately three or four rounds of Google Forms-based Delphi questionnaires. The Experts will provide opinion on the problem areas; definition and management of acute RVI in patients receiving ECMO for respiratory support. The survey is organised into three domains: Definition, RVI severity, Management strategies, and Research Priorities. The problem areas, domains and statements were generated by systematic literature review. Most of these statements require a 7-point Likert scale rating or selecting appropriate options in multiple-choice questions (MCQs). In round one, there is an option to collect feedback from participating Experts in the offered open area, which will be evaluated before the round two questionnaire. Rounds are repeated until consensus (or stable dissensus) is reached (≥70% for the Likert scale and ≥80% for MCQs). Experts will be presented with the summary results of each round, and the survey procedure will be repeated with the amended questionnaire. The Delphi rounds will continue until the required consensus (or lack thereof) and statement stability is obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals involved in the management adult patients receiving Extracorporeal Membrane Oxygenation.
Key inclusion criteria (2 listed)
- Working in an active Extracorporeal Life Support Organisation (ELSO) member centre for > 5 years, or clinical experience in cardiorespiratory failure for > 5 years.
- Original research in the field of ECMO or Cardiorespiratory failure (at least one peer-reviewed publication as a leading author).
Key exclusion criteria (1 listed)
- People who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi Rounds to generate consensus opinions among ExpertsThe Investigators (Steering Committee) will select the experts from across the globe based on pre-specified qualification criteria and will conduct iterative Delphi rounds to generate consensus on the definition and management of acute RVI in patients with receiving V-V ECMO, among the Experts. The selection criteria will be self-assessed through a survey among the potential Experts. | Behavioural | – |
Primary outcome
Consensus statements
Time frame: Through study completion, an average of 6 months
Consensus amongst the expert panel regarding RVI definition and management will be achieved using Delphi method which includes iterative rounds of questions; Consensus will be considered reached when a statement achieves >80% of votes for multiple-choice questions and >70% for Likert-scale statements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 34774188Nasa P, Azoulay E, Chakrabarti A, Divatia JV, Jain R, Rodrigues C, Rosenthal VD, Alhazzani W, Arabi YM, Bakker J, Bassetti M, De Waele J, Dimopoulos G, Du B, Einav S, Evans L, Finfer S, Guerin C, Hammond NE, Jaber S, Kleinpell RM, Koh Y, Kollef M, Levy MM, Machado FR, Mancebo J, Martin-Loeches I, Mer M, Niederman MS, Pelosi P, Perner A, Peter JV, Phua J, Piquilloud L, Pletz MW, Rhodes A, Schultz MJ, Singer M, Timsit JF, Venkatesh B, Vincent JL, Welte T, Myatra SN. Infection control in the intensive care unit: expert consensus statements for SARS-CoV-2 using a Delphi method. Lancet Infect Dis. 2022 Mar;22(3):e74-e87. doi: 10.1016/S1473-3099(21)00626-5. Epub 2021 Nov 10.
- Background: PubMed 31408142Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.
- Background: PubMed 35945343Supady A, Combes A, Barbaro RP, Camporota L, Diaz R, Fan E, Giani M, Hodgson C, Hough CL, Karagiannidis C, Kochanek M, Rabie AA, Riera J, Slutsky AS, Brodie D. Respiratory indications for ECMO: focus on COVID-19. Intensive Care Med. 2022 Oct;48(10):1326-1337. doi: 10.1007/s00134-022-06815-w. Epub 2022 Aug 9.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 37326646Grasselli G, Calfee CS, Camporota L, Poole D, Amato MBP, Antonelli M, Arabi YM, Baroncelli F, Beitler JR, Bellani G, Bellingan G, Blackwood B, Bos LDJ, Brochard L, Brodie D, Burns KEA, Combes A, D'Arrigo S, De Backer D, Demoule A, Einav S, Fan E, Ferguson ND, Frat JP, Gattinoni L, Guerin C, Herridge MS, Hodgson C, Hough CL, Jaber S, Juffermans NP, Karagiannidis C, Kesecioglu J, Kwizera A, Laffey JG, Mancebo J, Matthay MA, McAuley DF, Mercat A, Meyer NJ, Moss M, Munshi L, Myatra SN, Ng Gong M, Papazian L, Patel BK, Pellegrini M, Perner A, Pesenti A, Piquilloud L, Qiu H, Ranieri MV, Riviello E, Slutsky AS, Stapleton RD, Summers C, Thompson TB, Valente Barbas CS, Villar J, Ware LB, Weiss B, Zampieri FG, Azoulay E, Cecconi M; European Society of Intensive Care Medicine Taskforce on ARDS. ESICM guidelines on acute respiratory distress syndrome: definition, phenotyping and respiratory support strategies. Intensive Care Med. 2023 Jul;49(7):727-759. doi: 10.1007/s00134-023-07050-7. Epub 2023 Jun 16.
- Background: PubMed 26352116Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.
- Background: PubMed 33915103Matthay MA, Thompson BT, Ware LB. The Berlin definition of acute respiratory distress syndrome: should patients receiving high-flow nasal oxygen be included? Lancet Respir Med. 2021 Aug;9(8):933-936. doi: 10.1016/S2213-2600(21)00105-3. Epub 2021 Apr 27.
- Background: PubMed 34020703Sato R, Dugar S, Cheungpasitporn W, Schleicher M, Collier P, Vallabhajosyula S, Duggal A. The impact of right ventricular injury on the mortality in patients with acute respiratory distress syndrome: a systematic review and meta-analysis. Crit Care. 2021 May 21;25(1):172. doi: 10.1186/s13054-021-03591-9.
- Background: PubMed 36219228Zochios V, Yusuff H, Schmidt M; Protecting the Right Ventricle Network (PRORVnet). Acute right ventricular injury phenotyping in ARDS. Intensive Care Med. 2023 Jan;49(1):99-102. doi: 10.1007/s00134-022-06904-w. Epub 2022 Oct 11. No abstract available.
- Background: PubMed 35445822Huang S, Vignon P, Mekontso-Dessap A, Tran S, Prat G, Chew M, Balik M, Sanfilippo F, Banauch G, Clau-Terre F, Morelli A, De Backer D, Cholley B, Slama M, Charron C, Goudelin M, Bagate F, Bailly P, Blixt PJ, Masi P, Evrard B, Orde S, Mayo P, McLean AS, Vieillard-Baron A; ECHO-COVID research group. Echocardiography findings in COVID-19 patients admitted to intensive care units: a multi-national observational study (the ECHO-COVID study). Intensive Care Med. 2022 Jun;48(6):667-678. doi: 10.1007/s00134-022-06685-2. Epub 2022 Apr 21.
- Background: PubMed 29744563Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.
- Background: PubMed 28081831Vonk Noordegraaf A, Westerhof BE, Westerhof N. The Relationship Between the Right Ventricle and its Load in Pulmonary Hypertension. J Am Coll Cardiol. 2017 Jan 17;69(2):236-243. doi: 10.1016/j.jacc.2016.10.047.
- Individual participant dataSharing planned: No. Individual participant data will be kept anonymous and be shared after the Delphi process during the publication.
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Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Scheduled Cardiac Surgery With Extracorporeal Circulation, Vasoplegic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Zochios, MRCP FFICM principal investigator
University Hospitals of Leicester NHS Trust, Glenfied Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Circulation; Complications and Extracorporeal Membrane Oxygenation Complication, run by Prashant Nasa at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus statements (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948332, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.