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CompletedNCT05001841AKI_LUTXUpdated Aug 12, 2021

Renal Failure Following Lung Transplantation in Cystic Fibrosis Patients

An observational study in Cystic Fibrosis, sponsored by Policlinico Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Policlinico Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
85
Ages
18 Years and older
Sex
All
01

Study summary

With this retrospective observational cohort study, we performed a longitudinal assessment of the renal function of the adult CF patients who underwent LUTX, aiming 1) to describe possible risk factors associated with perioperative AKI and 2) to describe AKI short and long term effects on clinical outcomes.

Read the detailed description

This study is a retrospective analysis of prospectively collected data from medical records of all consecutive CF patients who underwent LUTX at our Institution from January 2013 to December 2018.

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Conditions studied

  • Cystic Fibrosis
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In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 85 is close to the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients undergone LUTX at a single Institution

Inclusion criteria

  • All patients with CF who underwent LUTX during the study period were considered.

Exclusion criteria

Exclusion Criteria:

  • single LUTX
  • re-transplantation
  • missing medical records;
  • age \< 18 years old
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
85 participants (actual)
Patient registry
No

Interventions

  • ProcedureLung Transplantation

    Double lung transplant

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What researchers measure

Primary outcomes

  1. Acute Kidney Injury

    AKI stage 1, stage 2, and stage 3 whether a 1.5-1.9 times, 2-2.9 times, and \>3 times increase from the preoperative creatinine was measured, respectively. Following KIDGO criteria

    Time frame: 1 month

Secondary outcomes

  1. Survival

    Death at follow-up

    Time frame: Until May 31 2021

Other outcomes

  1. Chronic Kidney Injury

    chronic kidney disease (CKD) at 1-year follow-up was defined according to KIDGO criteria: an eGFR between 90 to 60 mL/min/1.73 m2 was considered to be stage 2 CKD, between 30-to-59 mL/min/1.73 m2 was considered to be stage 3 CKD, between mL/min/1.73 m2 was classified as stage 4, and \< 15 mL/min/1.73 m2 (or need for dialysis or kidney transplant) was considered to be stage 5

    Time frame: 1 year after lung transplantation

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Study locations

1 site
  • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
    Milan, 20100, Italy
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References and documents

Individual participant data

Plan to share: Undecided — On request

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05001841
Lead sponsor
Policlinico Hospital
Responsible party
Giacomo Grasselli (Professor, Policlinico Hospital) — Principal investigator
First posted
Aug 12, 2021
Start date
Jan 1, 2013
Primary completion
Dec 31, 2018
Completion
May 31, 2021
Last update
Aug 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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