MicMac
Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass
Sponsor study identifier
observational
50
1 country
1
Study Start
February 10, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2025
Actual (reported)February 21, 2025
Actual (reported)July 11, 2025
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
All patients at high risk of vasoplegia syndrome after cardiac surgery because they have cardiopulmonary bypass during the surgery
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
Georges Pompidou European Hospital
Paris, 75015, France
Plasma
Helene NOUGUE, MCUPH
Georges Pompidou European Hospital
First Submitted
February 21, 2025
First Posted
July 11, 2025
Study Start
February 10, 2025
Actual (reported)Primary Completion
December 31, 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 11, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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