drugset / Trial / NCT04425031
Handling Oxygenation Targets in COVID-19
Phase 4
Completed
726 enrolled
Aalborg University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research · collabRigshospitalet, Denmark · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.
Timeline
- Start
- 2020-08-25
- Primary completion
- 2023-03-08
- Completion
- 2024-03-08
Outcome
Met primary endpoint
paper supplemental bootstrapped adjusted mean difference, 5.8 days [95% CI, 0.2-11.5 days]; P = .04 PMID 38501214 ↗
paper resulted in more days alive without life support in 90 days than targeting a Pao2 of 90 mm Hg. PMID 38501214 ↗
Publications
- Background Schjorring OL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Okkonen M, Siegemund M, Morgan M, Thormar KM, Rasmussen BS; HOT-ICU Investigators. Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)-Protocol for a randomised clinical trial comparing a lower vs a higher oxygenation target in adults with acute hypoxaemic respiratory failure. Acta Anaesthesiol Scand. 2019 Aug;63(7):956-965. doi: 10.1111/aas.13356. Epub 2019 Mar 18.
- Background Barbateskovic M, Schjorring OL, Jakobsen JC, Meyhoff CS, Rasmussen BS, Perner A, Wetterslev J. Oxygen supplementation for critically ill patients-A protocol for a systematic review. Acta Anaesthesiol Scand. 2018 Aug;62(7):1020-1030. doi: 10.1111/aas.13127. Epub 2018 Apr 30.
- Background Barbateskovic M, Schjorring OL, Russo Krauss S, Jakobsen JC, Meyhoff CS, Dahl RM, Rasmussen BS, Perner A, Wetterslev J. Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit. Cochrane Database Syst Rev. 2019 Nov 27;2019(11):CD012631. doi: 10.1002/14651858.CD012631.pub2.
- Background Rasmussen BS, Perner A, Wetterslev J, Meyhoff CS, Schjorring OL. Oxygenation targets in acutely ill patients: still a matter of debate. Lancet. 2018 Dec 8;392(10163):2436-2437. doi: 10.1016/S0140-6736(18)32201-3. No abstract available.
- Background Schjorring OL, Klitgaard TL, Perner A, Wetterslev J, Lange T, Keus F, Laake JH, Morgan M, Backlund M, Siegemund M, Thormar KM, Rasmussen BS. The handling oxygenation targets in the intensive care unit (HOT-ICU) trial: Detailed statistical analysis plan. Acta Anaesthesiol Scand. 2020 Jul;64(6):847-856. doi: 10.1111/aas.13569. Epub 2020 Mar 4.
- Results Nielsen FM, Klitgaard TL, Bruun NH, Moller MH, Schjorring OL, Rasmussen BS. Lower or higher oxygenation targets in the intensive care unit: an individual patient data meta-analysis. Intensive Care Med. 2024 Aug;50(8):1275-1286. doi: 10.1007/s00134-024-07523-3. Epub 2024 Jul 11.
- Results Nielsen FM, Klitgaard TL, Siegemund M, Laake JH, Thormar KM, Cole JM, Aagaard SR, Bunzel AG, Vestergaard SR, Langhoff PK, Pedersen CH, Hejlesen JO, Abdelhamid S, Dietz A, Gebhard CE, Zellweger N, Hollinger A, Poulsen LM, Weihe S, Andersen-Ranberg NC, Pedersen UG, Mathiesen O, Andreasen AS, Brix H, Thomsen JJ, Petersen CH, Bestle MH, Wichmann S, Lund MS, Mortensen KM, Brand BA, Haase N, Iversen SA, Marcussen KV, Brochner AC, Borup M, Grofte T, Hildebrandt T, Kjaer MN, Engstrom J, Lange T, Perner A, Schjorring OL, Rasmussen BS; HOT-COVID Trial Group. Lower vs Higher Oxygenation Target and Days Alive Without Life Support in COVID-19: The HOT-COVID Randomized Clinical Trial. JAMA. 2024 Apr 9;331(14):1185-1194. doi: 10.1001/jama.2024.2934.
- Crescioli E, Klitgaard TL, Riis JO, Weinreich UM, Jensen JS, Vestergaard SR, Bunzel AG, Eriksen ASB, Gudbjerg SH, Poulsen LM, Brochner AC, Mortensen CB, Haberlandt T, Meyer CN, Braagaard L, Mortensen J, Lange T, Perner A, Schjorring OL, Rasmussen BS. Oxygenation Targets and Long-Term Cognitive and Pulmonary Functions in Hypoxemic Respiratory Failure: A Clinical Trial. Am J Respir Crit Care Med. 2026 Mar 1;212(3):464-473. doi: 10.1164/rccm.202412-2499OC.
- Nielsen FM, Klitgaard TL, Granholm A, Lange T, Perner A, Schjorring OL, Rasmussen BS. Lower or Higher Oxygenation Targets in Patients With COVID-19 in the ICU: A Secondary Bayesian Analysis of the Handling Oxygenation Targets in COVID-19 Trial. Chest. 2025 Mar;167(3):757-767. doi: 10.1016/j.chest.2024.08.055. Epub 2024 Sep 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxygen | Other / unclassified | — | — |