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The use of Landiolol in mitral valve sUrgery: a raNdomized, controlled, double-blind triAl. (LUNA)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515934-34-00
Acronym
LUNA
Enrollment
1500
Registered
2024-11-12
Start date
2025-01-28
Completion date
Unknown
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-cardiac output syndrome (LCOS)

Brief summary

The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:, need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);, need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);, need for renal replacement therapy at any time during the intensive care unit stay.

Detailed description

Patients requiring prolonged (>48 h) catecholamine infusion;, patients with increased postoperative cardiac biomarkers (Troponin I or T);, patients with a reduction in left ventricular ejection fraction;, number of patients readmitted to hospital for cardiac reasons;, EQ-5D-5L questionnaire;, death.

Interventions

DRUGLandiobloc 300 mg polvere per soluzione per infusione

Sponsors

Ospedale San Raffaele S.r.l.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the reduction of the occurrence of postoperative low-cardiac output syndrome, defined following a recent JAMA publication (Cholley 2017) as the presence of at least one of the following:, need of prolonged catecholamine infusion (persisting beyond 48 hours after the initiation of the study drug);, need of circulatory mechanical assist devices in the postoperative period (if an intraaortic balloon pump was inserted preventively, the criteria will be met if patients are not weaned from the balloon within 96 hours);, need for renal replacement therapy at any time during the intensive care unit stay.

Secondary

MeasureTime frame
Patients requiring prolonged (>48 h) catecholamine infusion;, patients with increased postoperative cardiac biomarkers (Troponin I or T);, patients with a reduction in left ventricular ejection fraction;, number of patients readmitted to hospital for cardiac reasons;, EQ-5D-5L questionnaire;, death.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026