Septic ShockSEPSISPAMNCT01149278
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
A study testing maintain mean arterial pressure between 80-85 mm Hg and maintain mean arterial pressure between 65-70 mm Hg in people with Septic Shock and Arterial Pressure, run by University Hospital, Angers at 1 site in France.
Trial summary
The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Arterial Pressure, Hemodynamics
- What is being tested?
- maintain mean arterial pressure between 80-85 mm Hg and maintain mean arterial pressure between 65-70 mm Hg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Sep 2012
- 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 septic shock according criteria of Bone
- minimal dose of norepinephrine
- Written informed consent obtained from the patient or surrogate
Who cannot join
- Age < 18 years
- Pregnancy
- Participation in other trials with the same endpoints
- moribund
- absence of registration in french health care system
- patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)
- Conditions
- Septic Shock, Arterial Pressure, Hemodynamics, Mortality, Clinical Trial
- Being tested
- maintain mean arterial pressure between 80-85 mm Hg, maintain mean arterial pressure between 65-70 mm Hg
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintain mean arterial pressure between 80-85 mm HgDrug
protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg
maintain mean arterial pressure between 65-70 mm HgOther
protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| high pressure | Active comparator | Not described Receives: Drug: maintain mean arterial pressure between 80-85 mm Hg |
| normal pressure | Placebo comparator | Not described Receives: Other: maintain mean arterial pressure between 65-70 mm Hg |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: day 28
Secondary outcomes (6)
decrease in mortality at day 90
Measured: day 90
decrease in sequential organ failure assessment
Measured: day 1 to day 28
extra renal replacement free days
Measured: day 28
renal function
Measured: day 1 to day 28
amount of fluids
Measured: day 1 to end of shock
catecholamines free days
Measured: day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149278
- Sponsor's protocol ID
- PHRC09-01
- Acronym
- SEPSISPAM
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 5 Nov 2012
- Results posted
- No
Publications
Pirracchio R, Fong N, Legrand M. Heterogeneity in the response to a high vs low mean arterial pressure target in patients with septic shock a post hoc analysis of a randomized controlled trial. Intensive Care Med. 2025 Oct;51(10):1775-1783. doi: 10.1007/s00134-025-08104-8. Epub 2025 Sep 17.
PubMed 40960603Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
PubMed 24635770
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT01149278
- Acronym / sponsor ID
- SEPSISPAM / PHRC09-01
- Conditions
- Septic Shock, Arterial Pressure, Hemodynamics, Mortality, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Jun 2010 (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.
The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high pressure | Active comparator | Drug: maintain mean arterial pressure between 80-85 mm Hg |
| normal pressure | Placebo comparator | Other: maintain mean arterial pressure between 65-70 mm Hg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with septic shock according criteria of Bone
- minimal dose of norepinephrine
- Written informed consent obtained from the patient or surrogate
Key exclusion criteria (6 listed)
- Age < 18 years
- Pregnancy
- Participation in other trials with the same endpoints
- 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 |
|---|---|---|
| maintain mean arterial pressure between 80-85 mm Hgprotocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg | Drug | high pressure |
| maintain mean arterial pressure between 65-70 mm Hgprotocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg | Other | normal pressure |
Primary outcome
mortality
Time frame: day 28
6 secondary outcomes
decrease in mortality at day 90
Time frame: day 90
decrease in sequential organ failure assessment
Time frame: day 1 to day 28
extra renal replacement free days
Time frame: day 28
renal function
Time frame: day 1 to day 28
amount of fluids
Time frame: day 1 to end of shock
catecholamines free days
Time frame: day 1 to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2012.
- Derived from this study: PubMed 40960603Pirracchio R, Fong N, Legrand M. Heterogeneity in the response to a high vs low mean arterial pressure target in patients with septic shock a post hoc analysis of a randomized controlled trial. Intensive Care Med. 2025 Oct;51(10):1775-1783. doi: 10.1007/s00134-025-08104-8. Epub 2025 Sep 17.
- Derived from this study: PubMed 24635770Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.
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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 maintain mean arterial pressure between 80-85 mm Hg and maintain mean arterial pressure between 65-70 mm Hg in people with Septic Shock and Arterial Pressure, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Nov 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 NCT01149278, which also lists 2 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 5 Nov 2012.