Readmissions of Lung Transplant Patients in ICU.

Readmissions of Lung Transplant Patients in the Intensive Care Unit

A multi-centre, prospective and observational study was carried out from August 2012 to June 2016 in five Spanish tertiary-care university hospitals with well-established lung transplant programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba).

The study population comprised all consecutive adult lung transplant recipients who required ICUr (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).

Study Overview

• Status: Completed
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Other: Colection of clinical data

• Study Type: Observational
• Enrollment (Actual): 153

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

Lung transplant recipients who required ICU readmission.

Description

Inclusion Criteria:

• All consecutive adult lung transplant recipients who required ICU readmission (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).

Exclusion Criteria:

• ICU readmission < 8 days post-transplant discharge from ICU.
• ICU readmission for early postoperative care following lung transplantation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung transplant patients readmitted in ICU	Other: Colection of clinical data; Colection of clinical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Causes of ICU readmission in LT adults	To assess the principal causes of ICU readmission in LT adults.	Augist 1. 2012 - June 30, 2016
Predictors of ICU and hospital mortality.	To identify potential predictors of ICU and hospital mortality.	Augist 1. 2012 - June 30, 2016

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Instituto de Salud Carlos III
• Investigators: Study Chair: Cristopher Alan Mazo Torre, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PR(AG)101/2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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