Control of Arterial Blood PressurePhase 4INPRESSNCT01536470
Intraoperative Noradrenaline to Control Arterial Pressure (INPRESS Study)
A Phase 4 study testing noradrenaline and Ephedryne chorydrate in people with Control of Arterial Blood Pressure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Control of Arterial Blood Pressure
- What is being tested?
- noradrenaline and Ephedryne chorydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jul 2016
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- ASA score ≥ 2
- Planned and unplanned surgical procedures
- Abdominal, orthopaedic and vascular surgery
- Expected duration ≥ 2 hours
- AKI risk index ≥ class 3
Who cannot join
- Severe preoperative hypertension (not controlled)
- Creatinine clearance < 30 ml/min or preoperative dialysis
- Acute cardiac failure
- Preoperative sepsis
- Preoperative hemodynamic failure (shock)
- Intraoperative use of locoregional anaesthesia (epidural and spinal)
- Patient refusal
- Pregnancy and/or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Noradrenaline to Control Intraoperative Arterial Pressure in High-risk Surgical Patients: A Multicentre Prospective Randomized Controlled Trial
The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure.
Read the detailed description
The maintenance of arterial blood pressure is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery, but optimal strategy of intraoperative blood pressure management remains undetermined, especially in high-risk patients. Target ranges for arterial pressure are not clearly defined, and hypotension is usually defined as a systolic pressure of less than 80 mmHg or a decrease of more than 40% from baseline.
Traditionally, management of intraoperative hypotension consisted primarily of fluid administration whereas vasoconstrictors, such as Ephedrine chlorhydrate, are often used as a second line therapy. This may, however, expose patients to prolonged hypotension and to excessive fluid administration, and each of them may alter tissue oxygenation.
Recent experimental data have shown that noradrenaline, which has - and -adrenergic effects, has no detrimental effects on microcirculatory blood flow and tissue oxygenation in the intestinal tract. Because of anaesthesia-induced vasodilatation, the use of a continuous infusion of noradrenaline to increase systemic vascular resistance could be useful to prevent detrimental effects of compromised tissue perfusion, especially in high-risk surgical patients.
The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.
The investigators hypothesis is that maintenance of arterial blood pressure with noradrenaline could reduce postoperative organ dysfunction in high-risk surgical patients.
- Conditions
- Control of Arterial Blood Pressure
- Being tested
- noradrenaline, Ephedryne chorydrate
- Keywords
- Intraoperative hemodynamic, Arterial pressure, Postoperative complications, Intraoperative fluids, Noradrenaline
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noradrenalineOther
The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.
Ephedryne chorydrateOther
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline | Experimental | Continuous infusion of noradrenaline to maintain arterial blood pressure management in high-risk surgical patients Receives: Other: noradrenaline |
| Ephedrine chorhydrate | Experimental | Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline)using intravenous bolus of Ephedrine chorhydrate Receives: Other: Ephedryne chorydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of postoperative SIRS and at least one major organ dysfunction
Measured: day-7
Secondary outcomes (8)
Incidence of intraoperative hypotension
Measured: at day 7
Incidence of intraoperative hypertension
Measured: at day 7
Incidence of intraoperative bradycardia
Measured: at day 7
Intraoperative volume of fluid perfused
Measured: at day 7
Intraoperative blood losses
Measured: at day 7
Need for intraoperative transfusion
Measured: at day 7
Postoperative organ failure
Measured: at day 7
Biologic criteria: plasma concentration of NGAL, creatinine, CRP, serum lactate, troponine)
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Control of Arterial Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Aguettant laboratory
- Responsible party
- Sponsor
- Investigators
- Emmanuel FUTIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536470
- Sponsor's protocol ID
- CHU-0111
- Other IDs
- 2011-004232-66
- Acronym
- INPRESS
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2012
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Noradrenaline to Control Intraoperative Arterial Pressure in High-risk Surgical Patients: A Multicentre Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01536470
- Acronym / sponsor ID
- INPRESS / CHU-0111
- Conditions
- Control of Arterial Blood Pressure
- Keywords
- Intraoperative hemodynamic, Arterial pressure, Postoperative complications, Intraoperative fluids, Noradrenaline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Aguettant laboratory
- Study start
- Mar 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Feb 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.
The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure.
Detailed description
The maintenance of arterial blood pressure is essential for organ perfusion pressure. Intraoperative hypotension is a frequent complication both after induction and during maintenance of anaesthesia, ranging from 5% to 75% depending on the chosen definition. Tissue hypoperfusion exposes to the occurrence of a systemic inflammatory response syndrome and is a key determinant of postoperative complications. Persistent intraoperative hypotension has been reported as an important prognostic factor of postoperative morbidity and mortality. Adequate treatment of arterial hypotension is therefore of particular importance during surgery, but optimal strategy of intraoperative blood pressure management remains undetermined, especially in high-risk patients. Target ranges for arterial pressure are not clearly defined, and hypotension is usually defined as a systolic pressure of less than 80 mmHg or a decrease of more than 40% from baseline.
Traditionally, management of intraoperative hypotension consisted primarily of fluid administration whereas vasoconstrictors, such as Ephedrine chlorhydrate, are often used as a second line therapy. This may, however, expose patients to prolonged hypotension and to excessive fluid administration, and each of them may alter tissue oxygenation.
Recent experimental data have shown that noradrenaline, which has - and -adrenergic effects, has no detrimental effects on microcirculatory blood flow and tissue oxygenation in the intestinal tract. Because of anaesthesia-induced vasodilatation, the use of a continuous infusion of noradrenaline to increase systemic vascular resistance could be useful to prevent detrimental effects of compromised tissue perfusion, especially in high-risk surgical patients.
The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.
The investigators hypothesis is that maintenance of arterial blood pressure with noradrenaline could reduce postoperative organ dysfunction in high-risk surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline | Experimental | Other: noradrenalineContinuous infusion of noradrenaline to maintain arterial blood pressure management in high-risk surgical patients |
| Ephedrine chorhydrate | Experimental | Other: Ephedryne chorydrateConventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline)using intravenous bolus of Ephedrine chorhydrate |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 50 years
- ASA score ≥ 2
- Planned and unplanned surgical procedures
- Abdominal, orthopaedic and vascular surgery
- Expected duration ≥ 2 hours
Key exclusion criteria (8 listed)
- Severe preoperative hypertension (not controlled)
- Creatinine clearance < 30 ml/min or preoperative dialysis
- Acute cardiac failure
- Preoperative sepsis
- Preoperative hemodynamic failure (shock)
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 |
|---|---|---|
| noradrenalineThe primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate. | Other | Noradrenaline |
| Ephedryne chorydrate | Other | Ephedrine chorhydrate |
Primary outcome
Composite endpoint of postoperative SIRS and at least one major organ dysfunction
Time frame: day-7
8 secondary outcomes
Incidence of intraoperative hypotension
Time frame: at day 7
Incidence of intraoperative hypertension
Time frame: at day 7
Incidence of intraoperative bradycardia
Time frame: at day 7
Intraoperative volume of fluid perfused
Time frame: at day 7
Intraoperative blood losses
Time frame: at day 7
Need for intraoperative transfusion
Time frame: at day 7
Postoperative organ failure
Time frame: at day 7
Biologic criteria: plasma concentration of NGAL, creatinine, CRP, serum lactate, troponine)
Time frame: at day 7
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 10 Aug 2026.
- Results publication: PubMed 28973220Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
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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.
Emmanuel FUTIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing noradrenaline and Ephedryne chorydrate in people with Control of Arterial Blood Pressure, run by University Hospital, Clermont-Ferrand 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 6 inclusion and 8 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 10 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite endpoint of postoperative SIRS and at least one major organ dysfunction (time frame: day-7). 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 NCT01536470, which also lists 1 linked publication.
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 10 Aug 2026.