VasoplegiaNORAHPINCT05922982
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
A study testing norepinephrine weaning protocol and norepinephrine weaning protocol and guided by the HPI in people with Vasoplegia and Shock, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasoplegia, Shock, Norepinephrine
- What is being tested?
- norepinephrine weaning protocol and norepinephrine weaning protocol and guided by the HPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to Jul 2025
- 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
- Age > 18 years
- The patient was hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital.
- Patient scheduled for on-pomp cardiac surgery [coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery (valve and bypass grafting)].
- Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.
- On-pomp cardiac surgery in less than 48 hours.
- Hemodynamically stable patient with MAP > 65 mmHg for more than 4 hours on noradrenaline
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- Monitoring of MAP with a radial or femoral arterial catheter
- Social security beneficiary
- Signature of the consent to participate in the study by the patient, preoperatively
Who cannot join
- Permanent arrhythmia (atrial fibrillation, flutter, or frequent atrial extrasystoles).
- Treatment with dobutamine, epinephrine, or vasopressin analog
- Patients with preoperative chronic end-stage renal failure require postoperative extra-renal purification.
- Pregnant woman
- The patient is dependent on an internal or external pacemaker.
- Hypothermia < 36°.
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- Patient under mechanical circulatory assistance after cardiac surgery.
- Hemorrhagic shock
- Patient under guardianship or curators
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Christophe Beyls, MD, 0322087866, Beyls.Christophe@chu-amiens.fr
Osama Abou Arab, MD
About this study
In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.
This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.
The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.
- Conditions
- Vasoplegia, Shock, Norepinephrine, Surgery
- Being tested
- norepinephrine weaning protocol, norepinephrine weaning protocol and guided by the HPI
- Keywords
- vasoplegia, shock, hypotension prediction index, Acumen, CABG, norepinephrine, surgery
- Medical subject headings
- Vasoplegia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norepinephrine weaning protocolDrug
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol
norepinephrine weaning protocol and guided by the HPIDrug
MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device.
| Study group | Role | What they receive |
|---|---|---|
| Standard care arm | Active comparator | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol Receives: Drug: norepinephrine weaning protocol |
| Experimental arm (HPI-guided) | Experimental | MAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device. Receives: Drug: norepinephrine weaning protocol and guided by the HPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the duration of norepinephrine administration between both groups
The duration will be defined as the difference in time between the beginning of the study (day 0) and the end of the study protocol (day 3).
Measured: 72 hours
Secondary outcomes (15)
Number of norepinephrine protocol weaning failures
Number of norepinephrine protocol weaning failures, defined as persistent norepinephrine delivery 72 hours after the start of inclusion
Measured: 2 years
Prevalence of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure < 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Measured: 72 hours
Frequency of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure < 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Measured: 72 hours
Duration of hypotensive episodes monitored by the Acumen IQ® device
Hypotension is defined by the presence of a mean arterial pressure < 65 mmHg for a minimum duration of 30 seconds. Blood pressure must be invasive and monitored on the HemoSphere® monitor.
Measured: 72 hours
NE total dose
The NE (norepinephrine) total dose delivered during the research protocol phase (mg/kg) automatically calculated by the DianeRea® software (BowMedical, France).
Measured: 72 hours
Cumulative diuresis
The Cumulative diuresis (ml.kg.h) during protocol completion (H0 to H72) or when norepinephrine weaning is considered successful.
Measured: 72 hours
Volume of administrated fluids
Cumulative volume of administration of crystalloids, colloids, or blood products during protocol or when NE weaning is considered as successful.
Measured: 72 hours
Total dose of vasoactive drugs
Vaso-active drugs. The total dose of vasoactive drug initiation or reintroduction of NE after the weaning protocol calculated by the NEE and the VIS.
Measured: 72 hours
Number of stroke
Stroke (Any embolic, thrombotic or haemorrhagic cerebral event with persistent residual motor, sensory or cognitive dysfunction (eg, hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory) diagnosed on a cerebral scanner)
Measured: 72 hours
Number of myocardial infarction
Myocardial infarction diagnosed by the clinical presentation, serial changes on 12-lead electrocardiographic suggesting infarction, and rise in cardiac markers (preferably cardiac troponins) with at least one value above the 99th percentile of the upper reference limit.
Measured: 72 hours
Number of resuscitated cardiac arrest
Cessation of mechanical cardiac activity confirmed by the absence of clinical signs of blood flow
Measured: 72 hours
Number of acute kidney injury
Increase in serum creatinine of over 27 μmol/L within 48 hours or diuresis lower than 0.5 mL/kg/hour (KDIGO Guidelines).
Measured: 72 hours
Number of mesenteric ischaemia
Mesenteric ischaemia confirmed by imaging or exploratory laparotomy and/or ischaemic colitis confirmed by gastrointestinal endoscopy or exploratory laparotomy
Measured: 72 hours
Number of in-hospital mortality.
Mortality from surgery to hospital discharge
Measured: 72 hours
Number of 30 days hospital mortality
Mortality after surgery until 30 days follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Sep 2023
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
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 VasoplegiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922982
- Sponsor's protocol ID
- PI2023_843_0046
- Acronym
- NORAHPI
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beyls C, Lefebvre T, Mollet N, Boussault A, Meynier J, Abou-Arab O, Mahjoub Y. Norepinephrine weaning guided by the Hypotension Prediction Index in vasoplegic shock after cardiac surgery: protocol for a single-centre, open-label randomised controlled trial - the NORAHPI study. BMJ Open. 2024 Jun 26;14(6):e084499. doi: 10.1136/bmjopen-2024-084499.
PubMed 38926148
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05922982
- Acronym / sponsor ID
- NORAHPI / PI2023_843_0046
- Conditions
- Vasoplegia, Shock, Norepinephrine, Surgery
- Keywords
- vasoplegia, shock, hypotension prediction index, Acumen, CABG, norepinephrine, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Jun 2023 (actual)
- 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.
In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) < 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.
This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.
The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care arm | Active comparator | Drug: norepinephrine weaning protocolMAP-based (MAP > 65 mmHg) norepinephrine weaning protocol |
| Experimental arm (HPI-guided) | Experimental | Drug: norepinephrine weaning protocol and guided by the HPIMAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- The patient was hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital.
- Patient scheduled for on-pomp cardiac surgery [coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery (valve and bypass grafting)].
- Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.
- On-pomp cardiac surgery in less than 48 hours.
Key exclusion criteria (9 listed)
- Permanent arrhythmia (atrial fibrillation, flutter, or frequent atrial extrasystoles).
- Treatment with dobutamine, epinephrine, or vasopressin analog
- Patients with preoperative chronic end-stage renal failure require postoperative extra-renal purification.
- Pregnant woman
- The patient is dependent on an internal or external pacemaker.
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 |
|---|---|---|
| norepinephrine weaning protocolMAP-based (MAP > 65 mmHg) norepinephrine weaning protocol | Drug | Standard care arm |
| norepinephrine weaning protocol and guided by the HPIMAP-based (MAP > 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI<80) delivered by the Acumen IQ medical device. | Drug | Experimental arm (HPI-guided) |
Primary outcome
Comparison of the duration of norepinephrine administration between both groups
Time frame: 72 hours
The duration will be defined as the difference in time between the beginning of the study (day 0) and the end of the study protocol (day 3).
15 secondary outcomes
Number of norepinephrine protocol weaning failures
Time frame: 2 years
Prevalence of hypotensive episodes monitored by the Acumen IQ® device
Time frame: 72 hours
Frequency of hypotensive episodes monitored by the Acumen IQ® device
Time frame: 72 hours
Duration of hypotensive episodes monitored by the Acumen IQ® device
Time frame: 72 hours
NE total dose
Time frame: 72 hours
Cumulative diuresis
Time frame: 72 hours
Volume of administrated fluids
Time frame: 72 hours
Total dose of vasoactive drugs
Time frame: 72 hours
Number of stroke
Time frame: 72 hours
Number of myocardial infarction
Time frame: 72 hours
Number of resuscitated cardiac arrest
Time frame: 72 hours
Number of acute kidney injury
Time frame: 72 hours
Number of mesenteric ischaemia
Time frame: 72 hours
Number of in-hospital mortality.
Time frame: 72 hours
Number of 30 days hospital mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 38926148Beyls C, Lefebvre T, Mollet N, Boussault A, Meynier J, Abou-Arab O, Mahjoub Y. Norepinephrine weaning guided by the Hypotension Prediction Index in vasoplegic shock after cardiac surgery: protocol for a single-centre, open-label randomised controlled trial - the NORAHPI study. BMJ Open. 2024 Jun 26;14(6):e084499. doi: 10.1136/bmjopen-2024-084499.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing norepinephrine weaning protocol and norepinephrine weaning protocol and guided by the HPI in people with Vasoplegia and Shock, run by Centre Hospitalier Universitaire, Amiens 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe Beyls, MD (0322087866, beyls.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the duration of norepinephrine administration between both groups (time frame: 72 hours). 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 NCT05922982, 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 3 Jul 2024.