Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

NCT ID: NCT05922982

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-07-31

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard care arm

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol

Group Type: ACTIVE_COMPARATOR

norepinephrine weaning protocol

Intervention Type: DRUG

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol

Experimental arm (HPI-guided)

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.

Group Type: EXPERIMENTAL

norepinephrine weaning protocol and guided by the HPI

Intervention Type: DRUG

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.

Interventions

norepinephrine weaning protocol

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol

Intervention Type: DRUG

norepinephrine weaning protocol and guided by the HPI

MAP-based (MAP \> 65 mmHg) norepinephrine weaning protocol and guided by the HPI (HPI\<80) delivered by the Acumen IQ medical device.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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°.
• Patient under mechanical circulatory assistance after cardiac surgery.
• Hemorrhagic shock
• Patient under guardianship or curators

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe Beyls, MD

Role: CONTACT

beyls.christophe@chu-amiens.fr

0322087866

Facility Contacts

Christophe Beyls, MD

Role: primary

Beyls.Christophe@chu-amiens.fr

0322087866

References

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.

Reference Type: DERIVED

PMID: 38926148 (View on PubMed)

Other Identifiers

PI2023_843_0046

Identifier Type: -

Identifier Source: org_study_id