Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

Study Overview
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Brief Summary
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Bilateral Lung transplantation (LUTX) is performed in selected patients with end-stage respiratory failure. During surgery, pulmonary arteries are sequentially cross-clamped. This can cause acute heart failure and hemodynamic instability that eventually persist into the postoperative period, leading to the need for prolonged vasoactive support in the postoperative Intensive Care Unit. Levosimendan is a relatively new vasoactive-inotropic drug, with different pharmacodynamic properties. This observational retrospective cohort study primarily aims 1) to describe the need for prolonged vasoactive support; 2) to evaluate the risk factors for prolonged vasoactive support; 3) to assess the impact of prolonged vasoactive support on outcomes. The secondary aim is to describe the use of Levosimendan in this cohort of patients.

Official Title
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Postoperative Prolonged Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation: a Retrospective Analysis of Risk Factors and Impact on Outcomes

Conditions
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Lung Transplant; Complications

Intervention / Treatment
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* Drug: Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intensive Care Unit admission after Double Lung Transplant surgery. Exclusion Criteria: single Lung Transplantation; re-transplantation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vasoactive-inotropic drug use (VASO+)<br>All patients treated with vasoactive-inotropic drugs (epinephrine, norepinephrine, dobutamine, dopamine, and levosimendan) after 12 hours after Intensive Care Unit Admission were retrospectively classified in the VASO + cohort. | Drug: Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan<br>* Vasoactive-inotropic drugs were administered according to clinical decision of the doctor in charge.<br>|
| No vasoactive-inotropic drug (VASO -)<br>Patients treated with vasoactive-inotropic drugs (epinephrine, norepinephrine, dobutamine, dopamine, and levosimendan) in the first 12 hours after Intensive Care Unit Admission (ICU) or patients never treated with such drugs in ICU were retrospectively classified in the VASO - cohort. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of postoperative vasoactive support after LUTX | This outcome aims to describe the number of patients treated with vasoactive drugs after Lung Transplantation in Intensive Care Unit, and median dosage and duration of therapy. | February 2017 - July 2022 | 
| Postoperative vasoactive support use after LUTX risk factors. | This outcome aims to assess if preoperative characteristics or intraoperative events can represent risk or protecting factors for postoperative vasoactive drugs need. | February 2017 - July 2022 | 
| Vasoactive support after LUTX impacts on outcomes. | This outcome aims to assess if the vasoactive drug use in the postoperative management of Lung Transplanted patients impacts 1) mechanical ventilation duration; 2) Continuous Renal Replacement Therapy; 3) ICU and Hospital Length of Stay; 4) Primary Graft Dysfunction; 5) in-hospital mortality; 6) survival at July 31st, 2023. | February 2017 - July 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of Levosimendan use in post-operative LUTX patients. | This outcome aims to describe the number and the characteristics of patients treated with levosimendan. | February 2017 - July 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Transplant, Vasoactive drugs