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Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05702333
Acronym
VASO_LUTX
Enrollment
150
Registered
2023-01-27
Start date
2017-02-01
Completion date
2022-07-31
Last updated
2023-04-05

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

Conditions

Lung Transplant; Complications

Keywords

Lung Transplant, Vasoactive drugs

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.

Interventions

DRUGEpinephrine Norepinephrine Dobutamine Dopamine Levosimendan

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

Sponsors

Policlinico Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion criteria

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

Design outcomes

Primary

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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026