Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

NCT05702333 | Completed

• 1 other identifier: VASO_LUTX
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications

Keywords

Lung Transplant; Vasoactive drugs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

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

  February 2017 - July 2022

Study Arms (2)

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

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.

Interventions

Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan DRUG

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

Vasoactive-inotropic drug use (VASO+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Intensive Care Unit admission after Double Lung Transplant surgery.

You may not qualify if:

• single Lung Transplantation;
• re-transplantation.

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (4)

• 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.

  PMID: 9515837 BACKGROUND

• 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.

  PMID: 34910811 BACKGROUND

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

  PMID: 2189661 BACKGROUND

• 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.

  PMID: 16386607 BACKGROUND

Study Officials

• Vittorio Scaravilli, MD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: February 1, 2017
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)