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Completed

NCT Number: NCT05702333

Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

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.

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Key information

Conditions

Lung Transplant; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion criteria

  • single Lung Transplantation;
  • re-transplantation.

Treatment and study plan

Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan

Drug

Vasoactive-inotropic drugs were administered according to clinical decision of the doctor in charge.

Primary outcomes

  1. Need of postoperative vasoactive support after LUTX

    Time frame: 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.

  2. Postoperative vasoactive support use after LUTX risk factors.

    Time frame: 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.

  3. Vasoactive support after LUTX impacts on outcomes.

    Time frame: 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 outcomes

  1. Description of Levosimendan use in post-operative LUTX patients.

    Time frame: February 2017 - July 2022

    This outcome aims to describe the number and the characteristics of patients treated with levosimendan.

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

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

Acronym: VASO_LUTX

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2023
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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