Vasoactive-inotropic Support and Levosimendan Use After Lung Transplantation

NCT ID: NCT05702333

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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Epinephrine Norepinephrine Dobutamine Dopamine Levosimendan

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Intensive Care Unit admission after Double Lung Transplant surgery.

Exclusion Criteria

1. single Lung Transplantation;
2. re-transplantation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giacomo Grasselli

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vittorio Scaravilli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

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Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 9515837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34910811 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2189661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16386607 (View on PubMed)

Other Identifiers

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VASO_LUTX

Identifier Type: -

Identifier Source: org_study_id

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