Hypertension, Pulmonary ArterialRELIEPHNCT05029167

REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study)

A study testing Restrictive PaO2, Low normal MAP and Liberal PaO2 in people with Hypertension, Pulmonary Arterial and Out-Of-Hospital Cardiac Arrest, run by University of Southern Denmark at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Background: For patients with out-of-hospital cardiac arrest (OHCA) at the intensive care unit (ICU), oxygen therapy plays an important role in post resuscitation care. During hospitalisation, a lot of these patients occur with pulmonary arterial hypertension (PAH). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Pulmonary Arterial, Out-Of-Hospital Cardiac Arrest, Intensive Care Unit
What is being tested?: Restrictive PaO2, Low normal MAP and Liberal PaO2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteDenmark
Study dates: 11 Sep 2017to Dec 2023
Phase: Interventional
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

Who may be able to join

Age ≥18 years
OHCA of presumed cardiac cause
Sustained ROSC
Unconsciousness (Glasgow coma scale <8) after sustained ROSC

Who cannot join

Conscious patients (obeying verbal commands)
Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
In-hospital cardiac arrest
OHCA of presumed non-cardiac cause e.g. after trauma or dissection/rupture of major artery or cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
Suspected or confirmed acute intracranial bleeding

Show all 14Show fewer

Suspected or confirmed acute stroke
Unwitnessed asystole
Known limitations in therapy and Do Not Resuscitate-order
Known disease making 180 days survival unlikely
Known pre-arrest cerebral performance category 3 or 4
>4 hours (240 minutes) from ROSC to screening
Systolic blood pressure <80 mmHg in spite of fluid loading/vasopressor and/or inotropic medication/intra-aortic balloon pump/axial flow device
Temperature on admission <30°C

Trial locations and contacts

1 site in 1 country.

Mie Mørkøre, MS contact

+45 28555083

mie.moerk@outlook.dk

Rikke Ingerslev Stage, MS contact

+45 28569220

rikke.i.stage@gmail.com

Denmark1 site, 1 recruiting

Depart med Cardiothoracic Intensive Care, Odense University Hospital
Odense, Region Syddanmark, 5000
Henrik Schmidt, DMSci, Henrik.Schmidt@rsyd.dk
Henrik Schmidt, DMSci
Recruiting

Other trials in Denmark

About this study

Official title: REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study): a Substudy Protocol for a Randomised Clinical Trial

Methods: The RELIEPH trial is a substudy within the BOX (Blood pressure and OXygenation targets in post resuscitation care) trial. It is a single-center, parallel-group randomised controlled clinical trial. 300 patients with OHCA hospitalised at the ICU are allocated to one of the two oxygenation interventions, either a restrictive- (9-10 kPa) or liberal (13-14 kPa) oxygen target both within the recommended range. The primary outcome is the fraction of time with pulmonary hypertension (mPAP >25 mmHg) out of total time with mechanical ventilation. Secondary outcomes are: length of ICU stay among survivors, lactate clearance, right ventricular failure, 30 days mortality and plasma brain natriuretic peptide (BNP) level 48 hours from randomisation.

Discussion: This study hypothesises that a liberal target of oxygen reduces the time with PAH during mechanical ventilation compared to a restrictive oxygen target in patients with OHCA at the ICU. When completed, this study hopes to provide new knowledge regarding which oxygen target is beneficial for this group of patients.

Conditions: Hypertension, Pulmonary Arterial, Out-Of-Hospital Cardiac Arrest, Intensive Care Unit, Oxygen Therapy, Mechanical Ventilation, Resuscitation
Being tested: Restrictive PaO2, Low normal MAP, Liberal PaO2, High normal MAP
Keywords: Out-of-hospital cardiac arrest, Resuscitation, Oxygen, Intensive Care Unit, Mechanical ventilation, Pulmonary Hypertension
Medical subject headings: Pulmonary Arterial Hypertension, Out-of-Hospital Cardiac Arrest, Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Restrictive PaO2Other
Also called PaO2 target at 9-10 kPa.
Patients are randomized to a PaO2 target of 9-10 kPa (open-label).
Low normal MAPOther
Also called Mean arterial blood pressure at 63 mmHg.
The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by +10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 63 mmHg.
Liberal PaO2Other
Also called PaO2 target at 13-14 kPa.
Patients are randomized to a PaO2 target of 13-14 kPa (open-label).
High normal MAPOther
Also called Mean arterial blood pressure at 77 mmHg.
The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by -10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 77mmHg.

Study groups in NCT05029167
Study group	Role	What they receive
Restrictive PaO2 and low normal MAP	Active comparator	Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA. Receives: Other: Restrictive PaO2; Other: Low normal MAP
Restrictive PaO2 and high normal MAP	Active comparator	Patients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA. Receives: Other: Restrictive PaO2; Other: High normal MAP
Liberal PaO2 and low normal MAP	Active comparator	Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA. Receives: Other: Low normal MAP; Other: Liberal PaO2
Liberal PaO2 and high normal MAP	Active comparator	Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA. Receives: Other: Liberal PaO2; Other: High normal MAP

What is being measured

The primary outcome is the main question the study is designed to answer.

Pulmonary hypertension
Fraction of time with pulmonary hypertension (mPAP >25 mmHg) out of total time with mechanical ventilation.
Measured: Up to 30 days.

Secondary outcomes (5)

Length of ICU stay.
Length of ICU stay among survivors.
Measured: Up to 8 weeks.
Lactate clearance.
>30% reduction in lactate level.
Measured: 24 hours.
Right ventricular failure.
Cardiac index <2 and central venous pressure >18 mmHg.
Measured: Up to 8 weeks.
Mortality.
Dead or alive.
Measured: 30 days after ROSC.
Plasma brain natriuretic peptide.
Plasma brain natriuretic peptide level.
Measured: 48 hours from randomisation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 2017Dec 2023

First posted31 Aug 2021
Study start11 Sep 2017
Primary completionSep 2023 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Hypertension, Pulmonary ArterialStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The RELIEPH trial is a substudy of the BOX trial, which is a multicenter, randomised clinical trial with a 2x2 factorial design. Patients are allocated 1:1:1:1 to two interventions, respectively high- or low mean arterial pressures (double blinded) and restrictive- or liberal oxygenation (open label). The RELIEPH trial focuses on the oxygen intervention and only has access to data from one trial site. This makes the RELIEPH trial a single-center, parallel-group randomised controlled trial with patients allocated 1:1 to the oxygen target interventions.
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05029167
Sponsor's protocol ID: S-2021xxxx
Acronym: RELIEPH
Status last verified: May 2022
First submitted: 11 Aug 2021
Last updated: 1 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data obtained through this study may be provided to qualified researchers with academic interest in post-resuscitation care. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Publications

Zhang Z, Xu X. Lactate clearance is a useful biomarker for the prediction of all-cause mortality in critically ill patients: a systematic review and meta-analysis*. Crit Care Med. 2014 Sep;42(9):2118-25. doi: 10.1097/CCM.0000000000000405.
PubMed 24797375
Young P, Bailey M, Bellomo R, Bernard S, Dicker B, Freebairn R, Henderson S, Mackle D, McArthur C, McGuinness S, Smith T, Swain A, Weatherall M, Beasley R. HyperOxic Therapy OR NormOxic Therapy after out-of-hospital cardiac arrest (HOT OR NOT): a randomised controlled feasibility trial. Resuscitation. 2014 Dec;85(12):1686-91. doi: 10.1016/j.resuscitation.2014.09.011. Epub 2014 Sep 28.
PubMed 25261605
Yamamoto R, Yoshizawa J. Oxygen administration in patients recovering from cardiac arrest: a narrative review. J Intensive Care. 2020 Aug 12;8:60. doi: 10.1186/s40560-020-00477-w. eCollection 2020.
PubMed 32832091
Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.
PubMed 24355639
Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Siegemund M, Backlund M, Keus F, Laake JH, Morgan M, Thormar KM, Rosborg SA, Bisgaard J, Erntgaard AES, Lynnerup AH, Pedersen RL, Crescioli E, Gielstrup TC, Behzadi MT, Poulsen LM, Estrup S, Laigaard JP, Andersen C, Mortensen CB, Brand BA, White J, Jarnvig IL, Moller MH, Quist L, Bestle MH, Schonemann-Lund M, Kamper MK, Hindborg M, Hollinger A, Gebhard CE, Zellweger N, Meyhoff CS, Hjort M, Bech LK, Grofte T, Bundgaard H, Ostergaard LHM, Thyo MA, Hildebrandt T, Uslu B, Solling CG, Moller-Nielsen N, Brochner AC, Borup M, Okkonen M, Dieperink W, Pedersen UG, Andreasen AS, Buus L, Aslam TN, Winding RR, Schefold JC, Thorup SB, Iversen SA, Engstrom J, Kjaer MN, Rasmussen BS; HOT-ICU Investigators. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure. N Engl J Med. 2021 Apr 8;384(14):1301-1311. doi: 10.1056/NEJMoa2032510. Epub 2021 Jan 20.
PubMed 33471452
Panwar R, Hardie M, Bellomo R, Barrot L, Eastwood GM, Young PJ, Capellier G, Harrigan PW, Bailey M; CLOSE Study Investigators; ANZICS Clinical Trials Group. Conservative versus Liberal Oxygenation Targets for Mechanically Ventilated Patients. A Pilot Multicenter Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Jan 1;193(1):43-51. doi: 10.1164/rccm.201505-1019OC.
PubMed 26334785
Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C; European Resuscitation Council; European Society of Intensive Care Medicine. European Resuscitation Council and European Society of Intensive Care Medicine 2015 guidelines for post-resuscitation care. Intensive Care Med. 2015 Dec;41(12):2039-56. doi: 10.1007/s00134-015-4051-3.
PubMed 26464394
Nash G, Blennerhassett JB, Pontoppidan H. Pulmonary lesions associated with oxygen therapy and artificial ventilation. N Engl J Med. 1967 Feb 16;276(7):368-74. doi: 10.1056/NEJM196702162760702. No abstract available.
PubMed 6017244
Moudgil R, Michelakis ED, Archer SL. Hypoxic pulmonary vasoconstriction. J Appl Physiol (1985). 2005 Jan;98(1):390-403. doi: 10.1152/japplphysiol.00733.2004.
PubMed 15591309
McLaughlin VV, Shah SJ, Souza R, Humbert M. Management of pulmonary arterial hypertension. J Am Coll Cardiol. 2015 May 12;65(18):1976-97. doi: 10.1016/j.jacc.2015.03.540.
PubMed 25953750
Luecke T, Pelosi P. Clinical review: Positive end-expiratory pressure and cardiac output. Crit Care. 2005;9(6):607-21. doi: 10.1186/cc3877. Epub 2005 Oct 18.
PubMed 16356246
Kirkegaard H, Taccone FS, Skrifvars M, Soreide E. Postresuscitation Care after Out-of-hospital Cardiac Arrest: Clinical Update and Focus on Targeted Temperature Management. Anesthesiology. 2019 Jul;131(1):186-208. doi: 10.1097/ALN.0000000000002700.
PubMed 31021845
Huynh TN, Weigt SS, Sugar CA, Shapiro S, Kleerup EC. Prognostic factors and outcomes of patients with pulmonary hypertension admitted to the intensive care unit. J Crit Care. 2012 Dec;27(6):739.e7-13. doi: 10.1016/j.jcrc.2012.08.006. Epub 2012 Oct 22.
PubMed 23089677
Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. EuReCa ONE-27 Nations, ONE Europe, ONE Registry: A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe. Resuscitation. 2016 Aug;105:188-95. doi: 10.1016/j.resuscitation.2016.06.004. Epub 2016 Jun 16.
PubMed 27321577
Gomersall CD, Joynt GM, Freebairn RC, Lai CK, Oh TE. Oxygen therapy for hypercapnic patients with chronic obstructive pulmonary disease and acute respiratory failure: a randomized, controlled pilot study. Crit Care Med. 2002 Jan;30(1):113-6. doi: 10.1097/00003246-200201000-00018.
PubMed 11905405

Want to know more?

Mie Mørkøre, MS

+45 28555083

mie.moerk@outlook.dk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension, Pulmonary Arterial trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study): a Substudy Protocol for a Randomised Clinical Trial
ClinicalTrials.gov ID: NCT05029167
Acronym / sponsor ID: RELIEPH / S-2021xxxx
Conditions: Hypertension, Pulmonary Arterial, Out-Of-Hospital Cardiac Arrest, Intensive Care Unit, Oxygen Therapy, Mechanical Ventilation, Resuscitation
Keywords: Out-of-hospital cardiac arrest, Resuscitation, Oxygen, Intensive Care Unit, Mechanical ventilation, Pulmonary Hypertension
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: University of Southern DenmarkUniversity, hospital or other
Study start: 11 Sep 2017 (actual)
Primary completion: Sep 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 31 Aug 2021 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: The RELIEPH trial is a substudy of the BOX trial, which is a multicenter, randomised clinical trial with a 2x2 factorial design. Patients are allocated 1:1:1:1 to two interventions, respectively high- or low mean arterial pressures (double blinded) and restrictive- or liberal oxygenation (open label). The RELIEPH trial focuses on the oxygen intervention and only has access to data from one trial site. This makes the RELIEPH trial a single-center, parallel-group randomised controlled trial with patients allocated 1:1 to the oxygen target interventions.

Arm	Type	Receives
Restrictive PaO2 and low normal MAP	Active comparator	Other: Restrictive PaO2, Other: Low normal MAPPatients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
Restrictive PaO2 and high normal MAP	Active comparator	Other: Restrictive PaO2, Other: High normal MAPPatients receiving PaO2 9-10 kPa (68-75 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.
Liberal PaO2 and low normal MAP	Active comparator	Other: Low normal MAP, Other: Liberal PaO2Patients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 63 mmHg during targeted temperature management (36 hours) after OHCA.
Liberal PaO2 and high normal MAP	Active comparator	Other: Liberal PaO2, Other: High normal MAPPatients receiving PaO2 13-14 kPa (98-105 mmHg) and MAP 77 mmHg during targeted temperature management (36 hours) after OHCA.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18 years
OHCA of presumed cardiac cause
Sustained ROSC
Unconsciousness (Glasgow coma scale <8) after sustained ROSC

Key exclusion criteria (14 listed)

Conscious patients (obeying verbal commands)
Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
In-hospital cardiac arrest
OHCA of presumed non-cardiac cause e.g. after trauma or dissection/rupture of major artery or cardiac arrest caused by initial hypoxia (i.e. drowning, suffocation, hanging).
Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)

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
Restrictive PaO2Also: PaO2 target at 9-10 kPa.Patients are randomized to a PaO2 target of 9-10 kPa (open-label).	Other	Restrictive PaO2 and high normal MAP, Restrictive PaO2 and low normal MAP
Low normal MAPAlso: Mean arterial blood pressure at 63 mmHg.The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by +10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 63 mmHg.	Other	Liberal PaO2 and low normal MAP, Restrictive PaO2 and low normal MAP
Liberal PaO2Also: PaO2 target at 13-14 kPa.Patients are randomized to a PaO2 target of 13-14 kPa (open-label).	Other	Liberal PaO2 and high normal MAP, Liberal PaO2 and low normal MAP
High normal MAPAlso: Mean arterial blood pressure at 77 mmHg.The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by -10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 77mmHg.	Other	Liberal PaO2 and high normal MAP, Restrictive PaO2 and high normal MAP

Primary outcome

Pulmonary hypertension
Time frame: Up to 30 days.
Fraction of time with pulmonary hypertension (mPAP >25 mmHg) out of total time with mechanical ventilation.

5 secondary outcomes

Length of ICU stay.
Time frame: Up to 8 weeks.
Lactate clearance.
Time frame: 24 hours.
Right ventricular failure.
Time frame: Up to 8 weeks.
Mortality.
Time frame: 30 days after ROSC.
Plasma brain natriuretic peptide.
Time frame: 48 hours from randomisation.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Background: PubMed 24797375Zhang Z, Xu X. Lactate clearance is a useful biomarker for the prediction of all-cause mortality in critically ill patients: a systematic review and meta-analysis*. Crit Care Med. 2014 Sep;42(9):2118-25. doi: 10.1097/CCM.0000000000000405.
Background: PubMed 25261605Young P, Bailey M, Bellomo R, Bernard S, Dicker B, Freebairn R, Henderson S, Mackle D, McArthur C, McGuinness S, Smith T, Swain A, Weatherall M, Beasley R. HyperOxic Therapy OR NormOxic Therapy after out-of-hospital cardiac arrest (HOT OR NOT): a randomised controlled feasibility trial. Resuscitation. 2014 Dec;85(12):1686-91. doi: 10.1016/j.resuscitation.2014.09.011. Epub 2014 Sep 28.
Background: PubMed 32832091Yamamoto R, Yoshizawa J. Oxygen administration in patients recovering from cardiac arrest: a narrative review. J Intensive Care. 2020 Aug 12;8:60. doi: 10.1186/s40560-020-00477-w. eCollection 2020.
Background: PubMed 24355639Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.
Background: PubMed 33471452Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Siegemund M, Backlund M, Keus F, Laake JH, Morgan M, Thormar KM, Rosborg SA, Bisgaard J, Erntgaard AES, Lynnerup AH, Pedersen RL, Crescioli E, Gielstrup TC, Behzadi MT, Poulsen LM, Estrup S, Laigaard JP, Andersen C, Mortensen CB, Brand BA, White J, Jarnvig IL, Moller MH, Quist L, Bestle MH, Schonemann-Lund M, Kamper MK, Hindborg M, Hollinger A, Gebhard CE, Zellweger N, Meyhoff CS, Hjort M, Bech LK, Grofte T, Bundgaard H, Ostergaard LHM, Thyo MA, Hildebrandt T, Uslu B, Solling CG, Moller-Nielsen N, Brochner AC, Borup M, Okkonen M, Dieperink W, Pedersen UG, Andreasen AS, Buus L, Aslam TN, Winding RR, Schefold JC, Thorup SB, Iversen SA, Engstrom J, Kjaer MN, Rasmussen BS; HOT-ICU Investigators. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure. N Engl J Med. 2021 Apr 8;384(14):1301-1311. doi: 10.1056/NEJMoa2032510. Epub 2021 Jan 20.
Background: PubMed 26334785Panwar R, Hardie M, Bellomo R, Barrot L, Eastwood GM, Young PJ, Capellier G, Harrigan PW, Bailey M; CLOSE Study Investigators; ANZICS Clinical Trials Group. Conservative versus Liberal Oxygenation Targets for Mechanically Ventilated Patients. A Pilot Multicenter Randomized Controlled Trial. Am J Respir Crit Care Med. 2016 Jan 1;193(1):43-51. doi: 10.1164/rccm.201505-1019OC.
Background: PubMed 26464394Nolan JP, Soar J, Cariou A, Cronberg T, Moulaert VR, Deakin CD, Bottiger BW, Friberg H, Sunde K, Sandroni C; European Resuscitation Council; European Society of Intensive Care Medicine. European Resuscitation Council and European Society of Intensive Care Medicine 2015 guidelines for post-resuscitation care. Intensive Care Med. 2015 Dec;41(12):2039-56. doi: 10.1007/s00134-015-4051-3.
Background: PubMed 6017244Nash G, Blennerhassett JB, Pontoppidan H. Pulmonary lesions associated with oxygen therapy and artificial ventilation. N Engl J Med. 1967 Feb 16;276(7):368-74. doi: 10.1056/NEJM196702162760702. No abstract available.
Background: PubMed 15591309Moudgil R, Michelakis ED, Archer SL. Hypoxic pulmonary vasoconstriction. J Appl Physiol (1985). 2005 Jan;98(1):390-403. doi: 10.1152/japplphysiol.00733.2004.
Background: PubMed 25953750McLaughlin VV, Shah SJ, Souza R, Humbert M. Management of pulmonary arterial hypertension. J Am Coll Cardiol. 2015 May 12;65(18):1976-97. doi: 10.1016/j.jacc.2015.03.540.
Background: PubMed 16356246Luecke T, Pelosi P. Clinical review: Positive end-expiratory pressure and cardiac output. Crit Care. 2005;9(6):607-21. doi: 10.1186/cc3877. Epub 2005 Oct 18.
Background: PubMed 31021845Kirkegaard H, Taccone FS, Skrifvars M, Soreide E. Postresuscitation Care after Out-of-hospital Cardiac Arrest: Clinical Update and Focus on Targeted Temperature Management. Anesthesiology. 2019 Jul;131(1):186-208. doi: 10.1097/ALN.0000000000002700.
Blood Pressure and OXygenation Targets After OHCALink provided by the sponsor.
Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in post-resuscitation care. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

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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.

Mie Mørkøre, MS contact

+45 28555083

mie.moerk@outlook.dk

Rikke Ingerslev Stage, MS contact

+45 28569220

rikke.i.stage@gmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Jun 2022. 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 Denmark. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mie Mørkøre, MS (+45 28555083, mie.moerk@outlook.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulmonary hypertension (time frame: Up to 30 days.). 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 NCT05029167, which also lists 19 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 1 Jun 2022.