Hyperoxia and Hypertonic Saline in Septic Shock (Hyper2S)

November 19, 2014 updated by: University Hospital, Angers
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

441

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: day 28
day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: day 90
day 90
evolution of organ failures
Time Frame: day 1 to day 28
day 1 to day 28
catecholamines free days
Time Frame: day 1 to day 28
day 1 to day 28
mechanical ventilation free days
Time Frame: day 1 to day 28
day 1 to day 28
safety data
Time Frame: day 1 to day 90
day 1 to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRC 11-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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