Hyperoxia and Hypertonic Saline in Septic Shock (Hyper2S)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01722422 |
Recruitment Status :
Terminated
First Posted : November 6, 2012
Last Update Posted : November 20, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septic Shock Adult Respiratory Distress Syndrome | Drug: oxygen and saline | Not Applicable |
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 |

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 |
- all-cause mortality [ Time Frame: day 28 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
France | |
University Hospital Angers | |
Angers, France, 49933 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
sepsis shock hyperoxia hypertonic saline |
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 |