Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

Completed

• Conditions: Lung Transplant; Complications
• Interventions: Drug: Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan

• Registration Number: NCT05702333
• Lead Sponsor: Policlinico Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria

1. single Lung Transplantation;
2. re-transplantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vasoactive-inotropic drug use (VASO+)	Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan	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.

Primary Outcome Measures

Name	Time	Method
Postoperative vasoactive support use after LUTX risk factors.	February 2017 - July 2022	This outcome aims to assess if preoperative characteristics or intraoperative events can represent risk or protecting factors for postoperative vasoactive drugs need.
Need of postoperative vasoactive support after LUTX	February 2017 - July 2022	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.
Vasoactive support after LUTX impacts on outcomes.	February 2017 - July 2022	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy