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Completed

NCT Number: NCT03046277

Short- and Long-Term Renal Outcomes Following Lung Transplantation

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

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Key information

Conditions

Lung Transplantation Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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

  4. Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation.

    Time frame: 7 days

    AKI defined by KDIGO consensus criteria

  5. Association between pretransplant renal functional reserve and renal function loss after lung transplantation.

    Time frame: 1 year

    24h-creatinine clearance, estimated glomerular filtration rate

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2017
Registry last updated
Feb 5, 2020

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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