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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
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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

Arms and Interventions
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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
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Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: day 90 ]
  2. evolution of organ failures [ Time Frame: day 1 to day 28 ]
  3. catecholamines free days [ Time Frame: day 1 to day 28 ]
  4. mechanical ventilation free days [ Time Frame: day 1 to day 28 ]
  5. 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
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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
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Publications:

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

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