Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.

NCT07059715 | Recruiting

• 1 other identifier: 2024-A01235-42
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU. The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following resuscitation. In addition to all the monitors investigators usually use to monitor vital parameters during this type of procedure, investigators use sensors placed on the skin at the earlobe and palm of the hand to assess the quality of blood circulating in the body. The investigators would like to know if these observations help us to better understand the vasoplegic syndrome (persistent drop in blood pressure requiring the administration of medication to maintain normal blood pressure), a known but poorly understood complication following cardiac surgery under extracorporeal circulation. Extracorporeal circulation is the pump that keeps the blood circulating in your body when the heart is stopped while the surgeon works on the heart.

Conditions

Vasoplegic Syndrome of Cardiac Surgery

Keywords

vasoplegia syndrome; post cardiopulmonary bypass; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• Change in blood neprilysin activity.

  Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry. Unit of Measure: pmol/mL/min

  From enrollment (preoperative) to 48 hours after cardiac surgery

• Change in blood neprilysin concentration

  Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry. Unit of Measure: µg/L

  From enrollment (preoperative) to 48 hours after cardiac surgery

Secondary Outcomes (21)

• Change in cardiac output.

  From enrollment (preoperative) to 48 hours after cardiac surgery.

• Change in mean arterial pressure

  From enrollment (preoperative) to 48 hours after cardiac surgery

• Change un skin marbling score

  From enrollment (preoperative) to 48 hours after cardiac surgery

• Change in skin recoloration time.

  From enrollment (preoperative) to 48 hours after cardiac surgery

• vasopressor requirement variation

  From enrollment (preoperative) to 48 hours after cardiac surgery

Study Arms (1)

Patients at risk of vasoplegia syndrome after cardiac surgery

All patients at high risk of vasoplegia syndrome after cardiac surgery because they have cardiopulmonary bypass during the surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is all patients with risk factors at post operative vasoplegia syndrome (3 points or more in "inclusion criteria") who will have a cardiac surgery in the Georges Pompidou European Hospital

You may qualify if:

• Have at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:
• Acute or chronic heart failure with left ventricular ejection fraction\< 40% (1 pt)
• Complex cardiac surgery ( 2 pts)
• Cardiovascular risk factors with a EuroSCORE\> 4% (1 pt)
• Chronic Kidney Disease Stage 4
• Type 2 Diabetes Mellitus
• Pre-operative heparin treatment
• Hypothyroidism
• Anti-hypertensive treatments including an ACE inhibitor, an angiotensin II receptor antagonist, a beta-blocker or Sacubitril

You may not qualify if:

• Heart transplantation
• Pre-operative hemodynamic instability
• Pregnant women
• Age \<18
• Pre-existing sepsis
• Extracorporeal circulation support
• Heartmate/Impella/Carmat patient
• Hypothalamo-hypophyseal pathologies
• Adrenal insufficiency
• Anuric patient
• Guardianship/ curatorship
• Lack of social security coverage
• Opposition to clinical research by patients or their families

Sponsors & Collaborators

• European Georges Pompidou Hospital: lead

Study Sites (1)

Georges Pompidou European Hospital

Paris, 75015, France

RECRUITING

Related Links

• . Gökdemir, Begüm Nemika, et Nedim Çekmen. " Vasoplegic Syndrome and Anaesthesia: A Narrative Review ". Turkish Journal of Anaesthesiology and Reanimation 51, no 4 (1 august 2023): 280 89.
• . Vodovar, Nicolas, Marie-France Séronde, Said Laribi, Etienne Gayat, Johan Lassus, James L. Januzzi, Riadh Boukef, et al. " Elevated Plasma B-Type Natriuretic Peptide Concentrations Directly Inhibit Circulating Neprilysin Activity in Heart Failure ". JA

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

• Helene NOUGUE, MCUPH

  Georges Pompidou European Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène NOUGUE, MCU-PH

CONTACT

+331 56 09 25 94; helene.nougue@aphp.fr

Bernard Cholley, PUPH

CONTACT

+331 56 09 25 15; bernard.cholley@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordinator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: July 11, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)