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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Georges Pompidou Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Heart transplantation

Pre-operative hemodynamic instability

Pregnant women

Age <18

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Patients at risk of vasoplegia syndrome after cardiac surgery

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery
2

Change in blood neprilysin concentration

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

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery

Secondary outcomes

1

Change in cardiac output.

Change in cardiac output (L/min) assess using transthoracic, transesophageal ultrasound or invasive hemodynamic monitoring (FloTrac, Hemosphere,...).

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery.
2

Change in mean arterial pressure

Mean arterial pressure is continuously monitor with an arterial catheter and record in mmHg.

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery
3

Change un skin marbling score

Marbling is assessed using a validated ordinal scale (from 0: no marbling to 5: intense marbling) on the anterior knee surface. Score changes is used to evaluate peripheral perfusion and microcirculatory system.

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery
4

Change in skin recoloration time.

Skin recoloration time is measured in seconds after fingertip pressure and a return to the initial skin color. This time reflects peripheral perfusion and microcirculatory status.

Time frame
From enrollment (preoperative) to 48 hours after cardiac surgery

Other outcomes

Sponsors and contacts

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