Preoperative Evaluation of Microcirculation for Prediction of Complications After Cardiac Surgery

Extracorporeal Circulation; Complications Clinical Trial

— MONS  

Official title:

L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631797
• Other study ID #: 2018-A2341-54
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: April 26, 2019

Study information

• Verified date: June 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Eligible patients are included during the preoperative assessment. Written consent is signed after complete explanation of the protocol.

Patient characteristics as treatments, medical history, and EuroSCORE II are registered. Moreover, intraoperative data is collected. Psycho-cognitive and functional evaluation is made preoperatively.

Microcirculation is evaluated for each patient before surgery. Complications are registered at the end of hospital stay. Psycho-cognitive and functional evaluation is repeated by call 30 days after the surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Extracorporeal Circulation; Complications

Intervention

Procedure:
• Microvascular reactivity evaluation
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.

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of degree of disability	Change of modified Rankin scale	Inclusion and 30 days after surgery
Secondary	Functional evolution	Change of ADL score	Inclusion and 30 days after surgery
Secondary	Mood evolution	Change of brief Geriatric Depression Scale	Inclusion and 30 days after surgery
Secondary	Cognitive evolution	Change of Mc Nair test	Inclusion and 30 days after surgery