NCT01722422

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2012

Enrollment Period

1.9 years

First QC Date

November 2, 2012

Last Update Submit

November 19, 2014

Conditions

Septic ShockAdult Respiratory Distress Syndrome

Keywords

sepsisshockhyperoxiahypertonic saline

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    day 28

Secondary Outcomes (5)

  • all-cause mortality

    day 90

  • evolution of organ failures

    day 1 to day 28

  • catecholamines free days

    day 1 to day 28

  • mechanical ventilation free days

    day 1 to day 28

  • safety data

    day 1 to day 90

Study Arms (4)

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.

Drug: oxygen and saline

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.

Drug: oxygen and saline

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.

Drug: oxygen and saline

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.

Drug: oxygen and saline

Interventions

oxygen and salineDRUG
hyperoxia and 3% hypertonic salinehyperoxia and isotonic salinenormoxia and 3% hypertonic salinenormoxia and isotonic saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Angers

Angers, 49933, France

Location

Related Publications (7)

  • 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.

    PMID: 21164398BACKGROUND

  • 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.

    PMID: 7540812BACKGROUND

  • 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.

    PMID: 12415443BACKGROUND

  • 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.

    PMID: 9637711BACKGROUND

  • 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.

    PMID: 9137245BACKGROUND

  • 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.

    PMID: 31440853DERIVED

  • 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.

    PMID: 28219612DERIVED

MeSH Terms

Conditions

Shock, SepticRespiratory Distress SyndromeSepsisShockHyperoxia

Interventions

OxygenSodium Chloride

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 6, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 20, 2014

Record last verified: 2012-11

Locations

FR(1)