Hyperoxia and Hypertonic Saline in Septic Shock

University Hospital, Angers441 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

441

Conditions

Septic Shock Adult Respiratory Distress Syndrome

Interventions

oxygen and salineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Angers

Angers, France

Outcomes

Primary Outcomes

all-cause mortality

Time frame: day 28

Secondary Outcomes

all-cause mortality

Time frame: day 90

evolution of organ failures

Time frame: day 1 to day 28

catecholamines free days

Time frame: day 1 to day 28

mechanical ventilation free days

Time frame: day 1 to day 28

safety data

Time frame: day 1 to day 90

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.