NCT03631797

Brief Summary

Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications. Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
Last Updated

February 10, 2023

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

July 30, 2018

Last Update Submit

February 9, 2023

Conditions

Extracorporeal Circulation; Complications

Keywords

Thoracic SurgeryMicrocirculationEndothelium, vascularMicrovascular reactivityLaser Speckle

Outcome Measures

Primary Outcomes (1)

  • Postoperative complication

    Composite criteria and include microcirculation postoperative complications: * Late surgical re-intervention (greater than 12 hours) for evacuation of pericardial effusion (seeps), * Surgical wound disunion or surgical site infection, * Organ failure: SOFA score greater than 2 at 48h, * Postoperative confusion: assessed using the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), * Acute renal failure ≥ stage 2 according to the KDIGO classification, * Acute lung injury defined as PaO2 \<55mmHg in ambient air, PaO2 / FiO2 ratio \<250 or Pulse Oxygen Saturation (SpO2) \<90% and need for oxygen therapy, * Atrial fibrillation (excluding patients with permanent Atrial Fibrillation preoperatively), * Hepatocellular injury (Cytolysis \> 10N, Prothrombin rate and Factor V decreased \< 60%).

    30 postoperative days

Secondary Outcomes (4)

  • Evolution of degree of disability

    Inclusion and 30 days after surgery

  • Functional evolution

    Inclusion and 30 days after surgery

  • Mood evolution

    Inclusion and 30 days after surgery

  • Cognitive evolution

    Inclusion and 30 days after surgery

Study Arms (1)

Microvascular reactivity evaluation

EXPERIMENTAL

Patients referred for a preoperative arterial palmar arches assessment before cardiac valvular or coronary surgery. Intervention is measurement of microvascular reactivity with a laser speckle contrast imaging before surgery.

Procedure: Microvascular reactivity evaluation

Interventions

Microvascular reactivity evaluationPROCEDURE

Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.

Microvascular reactivity evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Valvular ou coronary elective cardiac surgery under cardiopulmonary bypass
  • Fair skin phototype
  • Ability to understand the study goal, no dementia.
  • Affiliation to the French National Healthcare System
  • Voluntary patients who have signed an informed consent

You may not qualify if:

  • Emergency surgery
  • Multiple procedures, combined surgery (valvular and coronary)
  • Single aortic surgery
  • Patient already included in the study (second surgery)
  • Patients protected by decision of law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Angers

Angers, 49933, France

Location

Related Publications (2)

  • Abrard S, Streichenberger A, Riou J, Hersant J, Rineau E, Jacquet-Lagreze M, Fouquet O, Henni S, Rimmele T. Preoperative endothelial dysfunction for the prediction of acute kidney injury after cardiac surgery using cardiopulmonary bypass: a pilot study based on a second analysis of the MONS study. Perioper Med (Lond). 2024 Feb 29;13(1):12. doi: 10.1186/s13741-024-00364-0.

    PMID: 38424616DERIVED

  • Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.

    PMID: 33411095DERIVED

Study Officials

  • Samir HENNI, MD PhD

    UH Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 15, 2018

Study Start

January 14, 2019

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

February 10, 2023

Record last verified: 2021-06

Locations

FR(1)