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Completed

NCT Number: NCT05001841

Renal Failure Following Lung Transplantation in Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lung Transplantation

Procedure

Double lung transplant

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 1 month

    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

Secondary outcomes

  1. Survival

    Time frame: Until May 31 2021

    Death at follow-up

Other outcomes

  1. Chronic Kidney Injury

    Time frame: 1 year after lung transplantation

    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

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Perioperative Acute Kidney Injury in Patients With Cystic Fibrosis Undergoing Lung Transplantation: a Retrospective Analysis

Acronym: AKI_LUTX

Important dates

Study start
2013
Primary completion
2018
Study completion
2021
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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