search
Back to results

Hyperoxia and Hypertonic Saline in Septic Shock (Hyper2S)

Primary Purpose

Septic Shock, Adult Respiratory Distress Syndrome

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
oxygen and saline
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring sepsis, shock, hyperoxia, hypertonic saline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Angers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

normoxia and isotonic saline

normoxia and 3% hypertonic saline

hyperoxia and isotonic saline

hyperoxia and 3% hypertonic saline

Arm Description

Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days.

Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.

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.

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.

Outcomes

Primary Outcome Measures

all-cause mortality

Secondary Outcome Measures

all-cause mortality
evolution of organ failures
catecholamines free days
mechanical ventilation free days
safety data

Full Information

First Posted
November 2, 2012
Last Updated
November 19, 2014
Sponsor
University Hospital, Angers
search

1. Study Identification

Unique Protocol Identification Number
NCT01722422
Brief Title
Hyperoxia and Hypertonic Saline in Septic Shock
Acronym
Hyper2S
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Adult Respiratory Distress Syndrome
Keywords
sepsis, shock, hyperoxia, hypertonic saline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normoxia and isotonic saline
Arm Type
Placebo Comparator
Arm Description
Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days.
Arm Title
normoxia and 3% hypertonic saline
Arm Type
Active Comparator
Arm Description
Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days.
Arm Title
hyperoxia and isotonic saline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
hyperoxia and 3% hypertonic saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxygen and saline
Primary Outcome Measure Information:
Title
all-cause mortality
Time Frame
day 28
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
day 90
Title
evolution of organ failures
Time Frame
day 1 to day 28
Title
catecholamines free days
Time Frame
day 1 to day 28
Title
mechanical ventilation free days
Time Frame
day 1 to day 28
Title
safety data
Time Frame
day 1 to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Angers
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21164398
Citation
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.
Results Reference
background
PubMed Identifier
7540812
Citation
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.
Results Reference
background
PubMed Identifier
12415443
Citation
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.
Results Reference
background
PubMed Identifier
9637711
Citation
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.
Results Reference
background
PubMed Identifier
9137245
Citation
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.
Results Reference
background
PubMed Identifier
31440853
Citation
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.
Results Reference
derived
PubMed Identifier
28219612
Citation
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. Erratum In: Lancet Respir Med. 2017 Aug;5(8):e28.
Results Reference
derived

Learn more about this trial

Hyperoxia and Hypertonic Saline in Septic Shock

We'll reach out to this number within 24 hrs