Hyperoxia and Hypertonic Saline in Septic Shock

Conditions

Adult Respiratory Distress Syndrome, Septic Shock

Keywords

sepsis, shock, hyperoxia, hypertonic saline

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.

Commereuc M, Nevoret C, Radermacher P, Katsahian S, Asfar P, Schortgen F, HYPER2S investigators.

2019-08-2222 citations

10.1186/s13613-019-0570-3

Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial.

Asfar P, Schortgen F, Boisramé-Helms J, Charpentier J, Guérot 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.

2017-02-15198 citations

10.1016/s2213-2600(17)30046-2

Interventions

DRUGoxygen and saline

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
all-cause mortality	day 28

Secondary

Measure	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

Countries

France

Outcome results

None listed