Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation (VASO_LUTX)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Drug: Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We retrospective enrolled all consecutive patients admitted to ICU after bilateral lung transplantation from February 2017 to July 2022.

Description

Inclusion Criteria:

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vasoactive-inotropic drug use (VASO+); 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; Vasoactive-inotropic drugs were administered according to clinical decision of the doctor in charge.
No vasoactive-inotropic drug (VASO -); 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?

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

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Principal Investigator: Vittorio Scaravilli, MD, University of Milan

Publications and helpful links

General Publications

• Mal H, Dehoux M, Sleiman C, Boczkowski J, Leseche G, Pariente R, Fournier M. Early release of proinflammatory cytokines after lung transplantation. Chest. 1998 Mar;113(3):645-51. doi: 10.1378/chest.113.3.645.
• Di Nardo M, Tikkanen J, Husain S, Singer LG, Cypel M, Ferguson ND, Keshavjee S, Del Sorbo L. Postoperative Management of Lung Transplant Recipients in the Intensive Care Unit. Anesthesiology. 2022 Mar 1;136(3):482-499. doi: 10.1097/ALN.0000000000004054.
• Todd TR. Early postoperative management following lung transplantation. Clin Chest Med. 1990 Jun;11(2):259-67.
• Guillen RV, Briones FR, Marin PM, Jover AS, Represa JM, Colom AP. Lung graft dysfunction in the early postoperative period after lung and heart lung transplantation. Transplant Proc. 2005 Nov;37(9):3994-5. doi: 10.1016/j.transproceed.2005.09.193.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lung Transplant; Vasoactive drugs
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Dopamine Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Vasoconstrictor Agents; Mydriatics; Phosphodiesterase 3 Inhibitors; Norepinephrine; Epinephrine; Simendan; Dopamine; Dobutamine
• Other Study ID Numbers: VASO_LUTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No