Septic ShockHyper2SNCT01722422
Hyperoxia and Hypertonic Saline in Septic Shock
A study testing oxygen and saline in people with Septic Shock and Adult Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Adult Respiratory Distress Syndrome
- What is being tested?
- oxygen and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 441 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Septic Shock, Adult Respiratory Distress Syndrome
- Being tested
- oxygen and saline
- Keywords
- sepsis, shock, hyperoxia, hypertonic saline
- Medical subject headings
- Shock, Septic, Respiratory Distress Syndrome, Sepsis, Shock, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen and salineDrug
| Study group | Role | What they receive |
|---|---|---|
| normoxia and isotonic saline | Placebo comparator | Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days. Receives: Drug: oxygen and saline |
| normoxia and 3% hypertonic saline | Active comparator | Administration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days. Receives: Drug: oxygen and saline |
| hyperoxia and isotonic saline | Active comparator | 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. Receives: Drug: oxygen and saline |
| hyperoxia and 3% hypertonic saline | Active comparator | 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. Receives: Drug: oxygen and saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: day 28
Secondary outcomes (5)
all-cause mortality
Measured: day 90
evolution of organ failures
Measured: day 1 to day 28
catecholamines free days
Measured: day 1 to day 28
mechanical ventilation free days
Measured: day 1 to day 28
safety data
Measured: day 1 to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722422
- Sponsor's protocol ID
- PHRC 11-05
- Acronym
- Hyper2S
- Status last verified
- Nov 2012
- First submitted
- 2 Nov 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calzia E, Asfar P, Hauser B, Matejovic M, Ballestra C, Radermacher P, Georgieff M. Hyperoxia may be beneficial. Crit Care Med. 2010 Oct;38(10 Suppl):S559-68. doi: 10.1097/CCM.0b013e3181f1fe70.
PubMed 21164398Goertz AW, Mehl T, Lindner KH, Rockemann MG, Schirmer U, Schwilk B, Georgieff M. Effect of 7.2% hypertonic saline/6% hetastarch on left ventricular contractility in anesthetized humans. Anesthesiology. 1995 Jun;82(6):1389-95. doi: 10.1097/00000542-199506000-00010.
PubMed 7540812Oliveira RP, Weingartner R, Ribas EO, Moraes RS, Friedman G. Acute haemodynamic effects of a hypertonic saline/dextran solution in stable patients with severe sepsis. Intensive Care Med. 2002 Nov;28(11):1574-81. doi: 10.1007/s00134-002-1509-x. Epub 2002 Oct 1.
PubMed 12415443Junger WG, Hoyt DB, Davis RE, Herdon-Remelius C, Namiki S, Junger H, Loomis W, Altman A. Hypertonicity regulates the function of human neutrophils by modulating chemoattractant receptor signaling and activating mitogen-activated protein kinase p38. J Clin Invest. 1998 Jun 15;101(12):2768-79. doi: 10.1172/JCI1354.
PubMed 9637711Coimbra R, Hoyt DB, Junger WG, Angle N, Wolf P, Loomis W, Evers MF. Hypertonic saline resuscitation decreases susceptibility to sepsis after hemorrhagic shock. J Trauma. 1997 Apr;42(4):602-6; discussion 606-7. doi: 10.1097/00005373-199704000-00004.
PubMed 9137245Commereuc M, Nevoret C, Radermacher P, Katsahian S, Asfar P, Schortgen F; HYPER2S investigators. Hyperchloremia is not associated with AKI or death in septic shock patients: results of a post hoc analysis of the "HYPER2S" trial. Ann Intensive Care. 2019 Aug 22;9(1):95. doi: 10.1186/s13613-019-0570-3.
PubMed 31440853Asfar P, Schortgen F, Boisrame-Helms J, Charpentier J, Guerot 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. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial. Lancet Respir Med. 2017 Mar;5(3):180-190. doi: 10.1016/S2213-2600(17)30046-2. Epub 2017 Feb 15.
PubMed 28219612
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxia and Hypertonic Saline in Septic Shock
- ClinicalTrials.gov ID
- NCT01722422
- Acronym / sponsor ID
- Hyper2S / PHRC 11-05
- Conditions
- Septic Shock, Adult Respiratory Distress Syndrome
- Keywords
- sepsis, shock, hyperoxia, hypertonic saline
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 441 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normoxia and isotonic saline | Placebo comparator | Drug: oxygen and salineAdministration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with isotonic saline during 3 days. |
| normoxia and 3% hypertonic saline | Active comparator | Drug: oxygen and salineAdministration of oxygen in order to maintain SaO2 between 88% and 95%. Fluid resuscitation if needed with 3% hypertonic saline during 3 days. |
| hyperoxia and isotonic saline | Active comparator | Drug: oxygen and salineAdministration 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. |
| hyperoxia and 3% hypertonic saline | Active comparator | Drug: oxygen and salineAdministration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- age < 18 years
- pregnancy
- participation in other trial with the same endpoint
- moribund
- absence of registration in french health care system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygen and saline | Drug | hyperoxia and 3% hypertonic saline, hyperoxia and isotonic saline, normoxia and 3% hypertonic saline, normoxia and isotonic saline |
Primary outcome
all-cause mortality
Time frame: day 28
5 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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Background: PubMed 21164398Calzia E, Asfar P, Hauser B, Matejovic M, Ballestra C, Radermacher P, Georgieff M. Hyperoxia may be beneficial. Crit Care Med. 2010 Oct;38(10 Suppl):S559-68. doi: 10.1097/CCM.0b013e3181f1fe70.
- Background: PubMed 7540812Goertz AW, Mehl T, Lindner KH, Rockemann MG, Schirmer U, Schwilk B, Georgieff M. Effect of 7.2% hypertonic saline/6% hetastarch on left ventricular contractility in anesthetized humans. Anesthesiology. 1995 Jun;82(6):1389-95. doi: 10.1097/00000542-199506000-00010.
- Background: PubMed 12415443Oliveira RP, Weingartner R, Ribas EO, Moraes RS, Friedman G. Acute haemodynamic effects of a hypertonic saline/dextran solution in stable patients with severe sepsis. Intensive Care Med. 2002 Nov;28(11):1574-81. doi: 10.1007/s00134-002-1509-x. Epub 2002 Oct 1.
- Background: PubMed 9637711Junger WG, Hoyt DB, Davis RE, Herdon-Remelius C, Namiki S, Junger H, Loomis W, Altman A. Hypertonicity regulates the function of human neutrophils by modulating chemoattractant receptor signaling and activating mitogen-activated protein kinase p38. J Clin Invest. 1998 Jun 15;101(12):2768-79. doi: 10.1172/JCI1354.
- Background: PubMed 9137245Coimbra R, Hoyt DB, Junger WG, Angle N, Wolf P, Loomis W, Evers MF. Hypertonic saline resuscitation decreases susceptibility to sepsis after hemorrhagic shock. J Trauma. 1997 Apr;42(4):602-6; discussion 606-7. doi: 10.1097/00005373-199704000-00004.
- Derived from this study: PubMed 31440853Commereuc M, Nevoret C, Radermacher P, Katsahian S, Asfar P, Schortgen F; HYPER2S investigators. Hyperchloremia is not associated with AKI or death in septic shock patients: results of a post hoc analysis of the "HYPER2S" trial. Ann Intensive Care. 2019 Aug 22;9(1):95. doi: 10.1186/s13613-019-0570-3.
- Derived from this study: PubMed 28219612Asfar P, Schortgen F, Boisrame-Helms J, Charpentier J, Guerot 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. Hyperoxia and hypertonic saline in patients with septic shock (HYPERS2S): a two-by-two factorial, multicentre, randomised, clinical trial. Lancet Respir Med. 2017 Mar;5(3):180-190. doi: 10.1016/S2213-2600(17)30046-2. Epub 2017 Feb 15.
Related trials for Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen and saline in people with Septic Shock and Adult Respiratory Distress Syndrome, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722422, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.