NCT05001841

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

6 years

First QC Date

July 24, 2021

Last Update Submit

August 3, 2021

Conditions

Cystic Fibrosis

Outcome Measures

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

    1 month

Secondary Outcomes (1)

  • Survival

    Until May 31 2021

Other Outcomes (1)

  • Chronic Kidney Injury

    1 year after lung transplantation

Interventions

Lung TransplantationPROCEDURE

Double lung transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergone LUTX at a single Institution

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pulmonary Surgical ProceduresThoracic Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 12, 2021

Study Start

January 1, 2013

Primary Completion

December 31, 2018

Study Completion

May 31, 2021

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

IT(1)