Lung Transplant; ComplicationsNCT03767049
Readmissions of Lung Transplant Patients in ICU.
An observational study of Lung Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Colection of clinical data
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2012to 30 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant recipients who required ICU readmission.
Who may be able to join
- 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).
Who cannot join
- ICU readmission < 8 days post-transplant discharge from ICU.
- ICU readmission for early postoperative care following lung transplantation.
About this study
Official title: 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).
- Conditions
- Lung Transplant; Complications
- Being tested
- Colection of clinical data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colection of clinical dataOther
Colection of clinical data
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant patients readmitted in ICU | Not described Receives: Other: Colection of clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Causes of ICU readmission in LT adults
To assess the principal causes of ICU readmission in LT adults.
Measured: Augist 1. 2012 - June 30, 2016
Predictors of ICU and hospital mortality.
To identify potential predictors of ICU and hospital mortality.
Measured: Augist 1. 2012 - June 30, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Aug 2012
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Cristopher Alan Mazo Torre, MD, Study chair, 0
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767049
- Sponsor's protocol ID
- PR(AG)101/2012
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Readmissions of Lung Transplant Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03767049
- Acronym / sponsor ID
- PR(AG)101/2012
- Conditions
- Lung Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant patients readmitted in ICU | – | Other: Colection of clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant recipients who required ICU readmission.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- ICU readmission < 8 days post-transplant discharge from ICU.
- ICU readmission for early postoperative care following lung transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colection of clinical dataColection of clinical data | Other | Lung transplant patients readmitted in ICU |
Primary outcome
Causes of ICU readmission in LT adults
Time frame: Augist 1. 2012 - June 30, 2016
To assess the principal causes of ICU readmission in LT adults.
Predictors of ICU and hospital mortality.
Time frame: Augist 1. 2012 - June 30, 2016
To identify potential predictors of ICU and hospital mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristopher Alan Mazo Torre, MD study chair
0
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Causes of ICU readmission in LT adults (time frame: Augist 1. 2012 - June 30, 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.