NCT03767049

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

3.9 years

First QC Date

December 5, 2018

Last Update Submit

December 5, 2018

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Lung transplant patients readmitted in ICU

Other: Colection of clinical data

Interventions

Colection of clinical dataOTHER

Colection of clinical data

Lung transplant patients readmitted in ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung transplant recipients who required ICU readmission.

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Cristopher Alan Mazo Torre, MD

    0

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

August 1, 2012

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

December 6, 2018

Record last verified: 2018-12