Skip to main content
OpenTrials
Completed

NCT Number: NCT03230136

Protection During Cardiac Surgery.

This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic Surgery Cardiopulmonary Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Annecy, Annecy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old
  • Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
  • Signed informed consent

Exclusion criteria

  • Emergency surgery
  • Redo surgery
  • Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
  • Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
  • Severe renal failure: dialysis or glomerular filtration rate < 30 mL/min
  • Severe liver failure (spontaneous INR >2)
  • Severe respiratory insufficiency (VEMS <40% of predicted value)
  • Contra-indication to sevoflurane and propofol
  • Myocardial infarction < 7 days
  • Severe upper limb arterial disease
  • Heparin-induced thrombopenia
  • Active infection under antibiotic treatment
  • Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
  • Pregnant women
  • Currently participating in another trial which may interfere with ProCCard results
  • Not benefiting from a social insurance or similar system
  • Patient under legal protection

Treatment and study plan

multimodal cardioprotection strategy

Other

Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).

standard anesthetic procedure

Other

standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I

    Time frame: at 72 hours

    Area under the plasma concentration versus time curve (AUC) of Hypersensitive Troponin I determined for each patient with the serial measurement from of troponin I assays.

Secondary outcomes

  1. Adverse events incidence during the first 30 days following surgery of the multimodal cardioprotection strategy

    Time frame: 30 days

    Adverse events will include death, myocardial infarction, heart failure,arrhythmia requiring medical therapy, neurological disorder such as stroke,respiratory insufficiency, any infectious event, major bleeding requiring transfusion of ≥ 5 U packed red blood cells or surgical intervention or surgical complication

  2. Troponin I serum peak value

    Time frame: 72 hours

    Highest serum value recorded for each patient within 72 hours

  3. Troponin I serum value

    Time frame: 24 hours

    Serum value recorded for each patient within 24 hours

  4. Length of mechanical ventilation

    Time frame: 30 days

  5. Length of stay in intensive care unit (ICU)

    Time frame: 30 days

  6. Length of stay in hospital

    Time frame: 30 days

  7. Index Gravity Score (IGS II, the scoring system measuring the severity of disease for patients admitted to ICU)

    Time frame: 24 hours

    Index Gravity Score provides an estimate of the risk of death: the higher the score is, the higher the risk to die is. The maximum score is 163. The Index Gravity Score includes 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy).

  8. Number of participants with catecholaminergic support

    Time frame: baseline and 30 days

  9. Dose of catecholaminergic support

    Time frame: baseline and 30 days

  10. 3-level version of EQ-5D (EQ-5D-3L) health status score (quality of life score)

    Time frame: Baseline and 30 days

    The 3-level version of EQ-5D consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).It comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

  11. number of death

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: ProCCard

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.