Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

Lung Transplant; Complications Clinical Trial

— VASO_LUTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702333
• Other study ID #: VASO_LUTX
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2023
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria:

1. single Lung Transplantation;

2. re-transplantation.

Related Conditions & MeSH terms

• Lung Transplant; Complications

Intervention

Drug:
• Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan
Vasoactive-inotropic drugs were administered according to clinical decision of the doctor in charge.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Todd TR. Early postoperative management following lung transplantation. Clin Chest Med. 1990 Jun;11(2):259-67. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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