Readmissions of Lung Transplant Patients in ICU.

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03767049
• Collaborator: Instituto de Salud Carlos III (Other)
• Enrollment: 153
• Actual Duration (Months): 46.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant; Complications	Other: Colection of clinical data

Study Design

• Study Type: Observational
• Actual Enrollment: 153 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Readmissions of Lung Transplant Patients in the Intensive Care Unit
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jun 30, 2016
• Actual Study Completion Date: Jun 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Causes of ICU readmission in LT adults [Augist 1. 2012 - June 30, 2016]

   To assess the principal causes of ICU readmission in LT adults.

2. Predictors of ICU and hospital mortality. [Augist 1. 2012 - June 30, 2016]

   To identify potential predictors of ICU and hospital mortality.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute
• Instituto de Salud Carlos III

Investigators

• Study Chair: Cristopher Alan Mazo Torre, MD, 0

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT03767049
• Other Study ID Numbers: PR(AG)101/2012
• First Posted: Dec 6, 2018
• Last Update Posted: Dec 6, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 6, 2018