Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass Surgery

NCT05685537 | Unknown DMC

• 1 other identifier: 2022_PI_118
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Levosimendan; Cardiac Surgery; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Length of stay in ICU

  To evaluate the impact of levosimendan preconditioning preoperatively for cardiac surgery on critical care length of stay in patients with heart failure with impaired preoperative LVAS.

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

Secondary Outcomes (7)

• On 1-year mortality

  1 year after Levosimendan exposure

• the total length of hospital stay

  start date of hospitalization in intensive care to the date of discharge from conventional sectors evaluated up to 3 months

• left ventricular systolic function at hospital discharge

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

• duration of catecholamine use after surgery

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

• severity of postcardiotomy cardiogenic shock and/or postoperative vasoplegia using the score Vasoactive Inotropic Score (VIS)

  date of start of intensive care hospitalization to date of discharge from intensive care hospitalization assessed up to 3 months

Study Arms (2)

Levosimendan - Interventional

Major patients in heart failure with 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 at the University Hospital of Rennes, Rouen or Amiens, and who have received Levosimendan preoperatively

Drug: Levosimendan

Non Levosimendan - Control

Major patients in heart failure with 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 at the University Hospital of Rennes, Rouen or Amiens, and who have not received Levosimendan preoperatively

Interventions

Levosimendan DRUG

Initiation of levosimendan 48 hours before surgery

Also known as: Interventional

Levosimendan - Interventional

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

'CHRU Nancy

Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54530, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 24781725 BACKGROUND

• 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.

  PMID: 29047417 BACKGROUND

• 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.

  PMID: 31358329 BACKGROUND

• 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.

  PMID: 28787507 BACKGROUND

• 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.

  PMID: 23620700 RESULT

MeSH Terms

Interventions

Simendan; Methods

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques

Study Officials

• KLEIN Thomas, MD

  Intensive care unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KLEIN THOMAS, MD

CONTACT

+33383154045; t.klein@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 17, 2023
• Study Start: December 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: February 15, 2023
• Last Updated: January 17, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)