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Assessment of the effect of hyperoxia and hypertonic saline on survival in patients with septic shock Hyperoxia and hypertonic saline may have beneficial effects on organ perfusion and oxygenation and may reduce the organ failure occurences. To date, only scarce data are available. Side effects are not well described. Therefore we designed a randomized clinical trial in order to assess the early administration of hypertonic saline and oxygen in the very early beginning of septic shock.
The study is designed as factorial 2x2. Patients will be stratified at the randomisation according the presence or absence of Acute Respiratory Distress Syndrome in order to perform a sub group analysis for all outcome criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normoxia and isotonic saline | Placebo Comparator | Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days. |
|
| normoxia and 3% hypertonic saline | Active Comparator | Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days. |
|
| hyperoxia and isotonic saline | Active Comparator | Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care. Fluid resuscitation if needed with isotonic saline during 3 days. |
|
| hyperoxia and 3% hypertonic saline | Active Comparator | Administration of oxygen with FiO2 = 100% during the first 24 hours and after switch oxygen administration to usual care. Fluid resuscitation if needed with 3% hypertonic saline during 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxygen and saline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | day 90 | |
| evolution of organ failures | day 1 to day 28 | |
| catecholamines free days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Angers | Angers | 49933 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21164398 | Background | Calzia E, Asfar P, Hauser B, Matejovic M, Ballestra C, Radermacher P, Georgieff M. Hyperoxia may be beneficial. Crit Care Med. 2010 Oct;38(10 Suppl):S559-68. doi: 10.1097/CCM.0b013e3181f1fe70. | |
| 7540812 | Background | Goertz AW, Mehl T, Lindner KH, Rockemann MG, Schirmer U, Schwilk B, Georgieff M. Effect of 7.2% hypertonic saline/6% hetastarch on left ventricular contractility in anesthetized humans. Anesthesiology. 1995 Jun;82(6):1389-95. doi: 10.1097/00000542-199506000-00010. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D012128 | Respiratory Distress Syndrome |
| D018805 | Sepsis |
| D012769 | Shock |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D002712 |
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| day 1 to day 28 |
| mechanical ventilation free days | day 1 to day 28 |
| safety data | day 1 to day 90 |
| 12415443 | Background | Oliveira RP, Weingartner R, Ribas EO, Moraes RS, Friedman G. Acute haemodynamic effects of a hypertonic saline/dextran solution in stable patients with severe sepsis. Intensive Care Med. 2002 Nov;28(11):1574-81. doi: 10.1007/s00134-002-1509-x. Epub 2002 Oct 1. |
| 9637711 | Background | Junger WG, Hoyt DB, Davis RE, Herdon-Remelius C, Namiki S, Junger H, Loomis W, Altman A. Hypertonicity regulates the function of human neutrophils by modulating chemoattractant receptor signaling and activating mitogen-activated protein kinase p38. J Clin Invest. 1998 Jun 15;101(12):2768-79. doi: 10.1172/JCI1354. |
| 9137245 | Background | Coimbra R, Hoyt DB, Junger WG, Angle N, Wolf P, Loomis W, Evers MF. Hypertonic saline resuscitation decreases susceptibility to sepsis after hemorrhagic shock. J Trauma. 1997 Apr;42(4):602-6; discussion 606-7. doi: 10.1097/00005373-199704000-00004. |
| 31440853 | Derived | Commereuc M, Nevoret C, Radermacher P, Katsahian S, Asfar P, Schortgen F; HYPER2S investigators. Hyperchloremia is not associated with AKI or death in septic shock patients: results of a post hoc analysis of the "HYPER2S" trial. Ann Intensive Care. 2019 Aug 22;9(1):95. doi: 10.1186/s13613-019-0570-3. |
| 28219612 | Derived | Asfar P, Schortgen F, Boisrame-Helms J, Charpentier J, Guerot E, Megarbane B, Grimaldi D, Grelon F, Anguel N, Lasocki S, Henry-Lagarrigue M, Gonzalez F, Legay F, Guitton C, Schenck M, Doise JM, Devaquet J, Van Der Linden T, Chatellier D, Rigaud JP, Dellamonica J, Tamion F, Meziani F, Mercat A, Dreyfuss D, Seegers V, Radermacher P; HYPER2S Investigators; REVA research network. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial. Lancet Respir Med. 2017 Mar;5(3):180-190. doi: 10.1016/S2213-2600(17)30046-2. Epub 2017 Feb 15. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |