Hyperoxia and Hypertonic Saline in Septic Shock (Hyper2S)

University Hospital, Angers

Status: Terminated

Conditions: Adult Respiratory Distress Syndrome; Septic Shock

Treatments: Drug: oxygen and saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01722422

PHRC 11-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 441 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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441 participants in 4 patient groups, including a placebo group

normoxia and isotonic saline

Placebo Comparator group

Description:

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

Treatment:

Drug: oxygen and saline

normoxia and 3% hypertonic saline

Active Comparator group

Description:

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

Treatment:

Drug: oxygen and saline

hyperoxia and isotonic saline

Active Comparator group

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.

Treatment:

Drug: oxygen and saline

hyperoxia and 3% hypertonic saline

Active Comparator group

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.

Treatment:

Drug: oxygen and saline