Readmissions of Lung Transplant Patients in ICU. | NCT03767049

Studies
Readmissions of Lung Transplant Patients in ICU.

NCT03767049

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Dec 6, 2018Actual

Enrollment

153Actual

Phase

Not provided

Conditions

Lung Transplant; Complications

Interventions

Colection of clinical data

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2012Actual

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Jun 30, 2016Actual

First Submitted Date

Dec 5, 2018

First Submission Date that Met QC Criteria

Dec 5, 2018

First Posted Date

Dec 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2018

Last Update Posted Date

Dec 6, 2018Actual

Name	Class
Instituto de Salud Carlos III	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lung transplant patients readmitted in ICU			Other: Colection of clinical data

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colection of clinical data	Other	Colection of clinical data	Lung transplant patients readmitted in ICU

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung transplant recipients who required ICU readmission.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Cristopher Alan Mazo Torre, MD	0	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided