Renal Failure Following Lung Transplantation in Cystic Fibrosis Patients (AKI_LUTX)

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Procedure: Lung Transplantation

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20100
    • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergone LUTX at a single Institution

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Death at follow-up	Until May 31 2021

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year after lung transplantation

Collaborators and Investigators

• Sponsor: Policlinico Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 346_2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: On request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No