Hyperoxia and Hypertonic Saline in Septic Shock

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Septic Shock, Adult Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: oxygen and saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normoxia and isotonic saline<br>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<br> <br> |
| Active Comparator: normoxia and 3% hypertonic saline<br>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<br> <br> |
| Active Comparator: hyperoxia and isotonic saline<br>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<br> <br> |
| Active Comparator: hyperoxia and 3% hypertonic saline<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, shock, hyperoxia, hypertonic saline