Hyperoxia and Hypertonic Saline in Septic Shock (Hyper2S)

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ClinicalTrials.gov Identifier: NCT01722422

Recruitment Status : Terminated

First Posted : November 6, 2012

Last Update Posted : November 20, 2014

Sponsor:

Information provided by (Responsible Party):

University Hospital, Angers

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Septic Shock Adult Respiratory Distress Syndrome	Drug: oxygen and saline	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	441 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Study Start Date :	October 2012
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Drug Information available for: Sodium chloride

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: normoxia and isotonic saline Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days.	Drug: oxygen and saline
Active Comparator: normoxia and 3% hypertonic saline Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.	Drug: oxygen and saline
Active Comparator: hyperoxia and isotonic saline 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.	Drug: oxygen and saline
Active Comparator: hyperoxia and 3% hypertonic saline 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.	Drug: oxygen and saline

Outcome Measures

Primary Outcome Measures :

all-cause mortality [ Time Frame: day 28 ]

Secondary Outcome Measures :

all-cause mortality [ Time Frame: day 90 ]
evolution of organ failures [ Time Frame: day 1 to day 28 ]
catecholamines free days [ Time Frame: day 1 to day 28 ]
mechanical ventilation free days [ Time Frame: day 1 to day 28 ]
safety data [ Time Frame: day 1 to day 90 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with less than 6 hours septic shock according criteria of Bone
minimal dose of catecholamines at least 0.1 µg/Kg/min
patient with mechanical ventilation
written informed consent

Exclusion Criteria:

age < 18 years
pregnancy
participation in other trial with the same endpoint
moribund
absence of registration in french health care system
patient protected by law
hypernatremia < 130 mmol/l ou > 145 mmol/l
patient with P/F < 100 mm Hg with PEEP > 5 cms of water
intracranial hypertension
patient admitted for cardiac arrest
overt cardiac failure

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722422

Locations

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France
University Hospital Angers
Angers, France, 49933

Sponsors and Collaborators

University Hospital, Angers

More Information

Publications:

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.

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.

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. Epub 2002 Oct 1.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Asfar P, Schortgen F, Boisramé-Helms J, Charpentier J, Guérot 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. Erratum in: Lancet Respir Med. 2017 Aug;5(8):e28.

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Responsible Party:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT01722422
Other Study ID Numbers:	PHRC 11-05
First Posted:	November 6, 2012 Key Record Dates
Last Update Posted:	November 20, 2014
Last Verified:	November 2012

Keywords provided by University Hospital, Angers:


sepsis shock hyperoxia hypertonic saline

Additional relevant MeSH terms:

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Shock, Septic Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Shock Pathologic Processes Lung Diseases Respiratory Tract Diseases	Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Lung Injury

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