Clinical trial NCT05702333: Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation
Official title: Postoperative Prolonged Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation: a Retrospective Analysis of Risk Factors and Impact on Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant; Complications
Keywords: Lung Transplant
Vasoactive drugs
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria:

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

Primary outcomes:
measure: Need of postoperative vasoactive support after LUTX
timeFrame: February 2017 - July 2022
measure: Postoperative vasoactive support use after LUTX risk factors.
timeFrame: February 2017 - July 2022
measure: Vasoactive support after LUTX impacts on outcomes.
timeFrame: February 2017 - July 2022
Secondary outcomes:
measure: Description of Levosimendan use in post-operative LUTX patients.
timeFrame: February 2017 - July 2022
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Study officials:
affiliation: University of Milan
name: Vittorio Scaravilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Todd TR. Early postoperative management following lung transplantation. Clin Chest Med. 1990 Jun;11(2):259-67.
citation: 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.