Clinical trial NCT05685537: Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery
Official title: Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Levosimendan
Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preoperative heart failure patients with impaired LVEF who underwent left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation from 01/09/2018 to 28/02/2022 at the CHRU de Nancy, CHRU de Rennes, CHRU de Rouen or CHRU d'Amiens.

Brief summary: Levosimendan, a drug with inotropic, vasodilatory and myocardial protective properties, has been proposed for the prevention and treatment of postoperative low cardiac output syndrome in cardiac surgery. Despite preliminary studies with promising results, large randomized controlled trials aimed at demonstrating the benefits of levosimendan did not show superiority over placebo in this indication. However, in these studies, the infusion was neither performed at the maximum dosage nor during the 24 hours preceding the surgery, but mainly at the very beginning of the operation. However, post hoc analyses showed a reduction in mortality and in the occurrence of low cardiac output syndrome in the subgroup of patients who had undergone isolated coronary artery bypass grafting, in contrast to those who had undergone valvular or combined surgery. Another recent study suggests that under similar conditions, preconditioning with levosimendan started 48 hours before surgery reduces the length of stay in intensive care and the average cost of hospitalization. There are no formal recommendations on the prophylactic use of levosimendan in cardiac surgery for heart failure patients with impaired LVAS. However, the France-Levo registry, a multicenter observational study requested by the HAS, has shown that in real practice there is a place for preconditioning with levosimendan, which is used in this indication for 7% of the patients in the registry. The Cardiovascular Surgery and Transplantation Department of the Nancy Brabois University Hospital, which actively participated in the France-Levo registry, is one of the cardiac surgery centers that uses this practice, as is the University Hospital of Rouen. It is interesting to be able to evaluate retrospectively whether levosimendan preconditioning has a positive impact on the postoperative prognosis of patients and more particularly on the reduction of the length of stay in critical care and in hospital compared to standard management.


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure impaired LVEF (\< 40%), who have undergone left heart surgery (coronary artery bypass grafting and/or mitral and/or aortic valve replacement) under extracorporeal circulation between 01/01/2018 and 28/02/2022 at the Nancy University Hospital or the University Hospital of Rennes, Rouen or Amiens

Exclusion Criteria:

* Initiation of levosimendan \> 48 hours or \< 24 hours before surgery
* ECMO pre- or post-op

Primary outcomes:
measure: Length of stay in ICU
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
Secondary outcomes:
measure: On 1-year mortality
timeFrame: 1 year after Levosimendan exposure
measure: the total length of hospital stay
timeFrame: start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months
measure: left ventricular systolic function at hospital discharge
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
measure: duration of catecholamine use after surgery
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
measure: severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)
timeFrame: date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months
measure: acute renal failure postoperatively
timeFrame: on discharge from the intensive care unit
measure: readmission rate for cardiac decompensation
timeFrame: within one year of Levosimendan administration
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: 'CHRU Nancy
state: Meurthe Et Moselle
Study officials:
affiliation: Intensive care unit
name: KLEIN Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erb J, Beutlhauser T, Feldheiser A, Schuster B, Treskatsch S, Grubitzsch H, Spies C. Influence of levosimendan on organ dysfunction in patients with severely reduced left ventricular function undergoing cardiac surgery. J Int Med Res. 2014 Jun;42(3):750-64. doi: 10.1177/0300060513516293. Epub 2014 Apr 29.
citation: Sanfilippo F, Knight JB, Scolletta S, Santonocito C, Pastore F, Lorini FL, Tritapepe L, Morelli A, Arcadipane A. Levosimendan for patients with severely reduced left ventricular systolic function and/or low cardiac output syndrome undergoing cardiac surgery: a systematic review and meta-analysis. Crit Care. 2017 Oct 19;21(1):252. doi: 10.1186/s13054-017-1849-0.
citation: van Diepen S, Mehta RH, Leimberger JD, Goodman SG, Fremes S, Jankowich R, Heringlake M, Anstrom KJ, Levy JH, Luber J, Nagpal AD, Duncan AE, Argenziano M, Toller W, Teoh K, Knight JD, Lopes RD, Cowper PA, Mark DB, Alexander JH. Levosimendan in patients with reduced left ventricular function undergoing isolated coronary or valve surgery. J Thorac Cardiovasc Surg. 2020 Jun;159(6):2302-2309.e6. doi: 10.1016/j.jtcvs.2019.06.020. Epub 2019 Jun 21.
citation: Cholley B, Caruba T, Grosjean S, Amour J, Ouattara A, Villacorta J, Miguet B, Guinet P, Levy F, Squara P, Ait Hamou N, Carillion A, Boyer J, Boughenou MF, Rosier S, Robin E, Radutoiu M, Durand M, Guidon C, Desebbe O, Charles-Nelson A, Menasche P, Rozec B, Girard C, Fellahi JL, Pirracchio R, Chatellier G; -. Effect of Levosimendan on Low Cardiac Output Syndrome in Patients With Low Ejection Fraction Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass: The LICORN Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):548-556. doi: 10.1001/jama.2017.9973.
citation: Levin R, Degrange M, Del Mazo C, Tanus E, Porcile R. Preoperative levosimendan decreases mortality and the development of low cardiac output in high-risk patients with severe left ventricular dysfunction undergoing coronary artery bypass grafting with cardiopulmonary bypass. Exp Clin Cardiol. 2012 Sep;17(3):125-30.