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

NCT05922982 | Recruiting

• 1 other identifier: PI2023_843_0046
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Keywords

vasoplegia; shock; hypotension prediction index; Acumen; CABG; norepinephrine; surgery

Outcome Measures

Primary Outcomes (1)

• 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).

  72 hours

Secondary Outcomes (15)

• Number of norepinephrine protocol weaning failures

  2 years

• Prevalence of hypotensive episodes monitored by the Acumen IQ® device

  72 hours

• Frequency of hypotensive episodes monitored by the Acumen IQ® device

  72 hours

• Duration of hypotensive episodes monitored by the Acumen IQ® device

  72 hours

• NE total dose

  72 hours

Study Arms (2)

Standard care arm

ACTIVE COMPARATOR

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

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.

Drug: norepinephrine weaning protocol and guided by the HPI

Interventions

norepinephrine weaning protocol DRUG

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

Standard care arm

norepinephrine weaning protocol and guided by the HPI DRUG

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

Experimental arm (HPI-guided)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 38926148 DERIVED

MeSH Terms

Conditions

Vasoplegia; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christophe Beyls, MD

CONTACT

0322087866; beyls.christophe@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)