Short- and Long-Term Renal Outcomes Following Lung Transplantation

February 3, 2020 updated by: Faeq Husain, University of Giessen

Short- and Long-Term Renal Outcomes Following Lung Transplantation- A Single-Centre Experience

Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease in patients undergoing lung transplantation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is well described that acute kidney injury and development of chronic kidney disease significantly impact short- and long-term survival after lung transplantation. However, there is limited data about prevalence of kidney disease according to current KDIGO consensus guidelines. It is the aim of this study to describe short- and long-term renal outcomes following lung transplantation. Selected patients who underwent prospective pretransplant renal functional reserve testing with high oral protein load will be analyzed separately in respect to occurrence of acute kidney injury following lung transplantation and development of chronic kidney disease.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • University Clinic Giessen and Marburg - Campus Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

All patients undergoing lung transplantation at University Hospital Giessen between 2003 and 2016. Subgroup of patients who underwent pretransplant renal functional reserve testing will be analyzed separately.

Description

For retrospective analysis for all patients undergoing lung transplantation:

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Patients with eGFR <15ml/min/1.73m2 or with chronic dialysis treatment prior LTx
  • Patients undergoing retransplantation and multiorgan transplantation

For prospective study involving patients with pretransplant renal functional reserve testing

Exclusion criteria:

  • as above
  • unable to perform renal functional reserve testing (e.g., due to critical illness)
  • pre-existing acute kidney injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing LTx
Retrospective analysis of clinical data
Other: No intervention
No intervention
Patients with pretransplant renal functional reserve testing
Prospective analysis of clinical data
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.
Time Frame: 7 days
AKI defined by KDIGO consensus criteria
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of sustained reversal versus non-recovery after AKI on long-term renal function decline after lung transplantation.
Time Frame: 3 years
AKI and CKD defined by KDIGO consensus criteria
3 years
Risk factors associated with development of AKI and CKD after lung transplantation
Time Frame: 3 years
AKI and CKD defined by KDIGO consensus criteria
3 years
Whether development of CKD is an independent risk factor for increased rejection rate and death after lung transplantation.
Time Frame: 3 years
CKD defined by KDIGO consensus criteria
3 years
Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation.
Time Frame: 7 days
AKI defined by KDIGO consensus criteria
7 days
Association between pretransplant renal functional reserve and renal function loss after lung transplantation.
Time Frame: 1 year
24h-creatinine clearance, estimated glomerular filtration rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Werner Seeger, MD, University Hospital Giessen and Marburg, Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

August 24, 2019

Study Completion (Actual)

August 24, 2019

Study Registration Dates

First Submitted

February 4, 2017

First Submitted That Met QC Criteria

February 4, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGiessen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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