Clinical trial NCT03046277: Short- and Long-Term Renal Outcomes Following Lung Transplantation
Official title: Short- and Long-Term Renal Outcomes Following Lung Transplantation- A Single-Centre Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Acute Kidney Injury
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.
timeFrame: 7 days
Secondary outcomes:
measure: Impact of sustained reversal versus non-recovery after AKI on long-term renal function decline after lung transplantation.
timeFrame: 3 years
measure: Risk factors associated with development of AKI and CKD after lung transplantation
timeFrame: 3 years
measure: Whether development of CKD is an independent risk factor for increased rejection rate and death after lung transplantation.
timeFrame: 3 years
measure: Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation.
timeFrame: 7 days
measure: Association between pretransplant renal functional reserve and renal function loss after lung transplantation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Clinic Giessen and Marburg - Campus Giessen
state: Hessen
Study officials:
affiliation: University Hospital Giessen and Marburg, Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.
citation: Fidalgo P, Ahmed M, Meyer SR, Lien D, Weinkauf J, Cardoso FS, Jackson K, Bagshaw SM. Incidence and outcomes of acute kidney injury following orthotopic lung transplantation: a population-based cohort study. Nephrol Dial Transplant. 2014 Sep;29(9):1702-9. doi: 10.1093/ndt/gfu226. Epub 2014 Jun 23.
citation: Fidalgo P, Ahmed M, Meyer SR, Lien D, Weinkauf J, Kapasi A, Cardoso FS, Jackson K, Bagshaw SM. Association between transient acute kidney injury and morbidity and mortality after lung transplantation: a retrospective cohort study. J Crit Care. 2014 Dec;29(6):1028-34. doi: 10.1016/j.jcrc.2014.07.024. Epub 2014 Jul 31.
citation: Canales M, Youssef P, Spong R, Ishani A, Savik K, Hertz M, Ibrahim HN. Predictors of chronic kidney disease in long-term survivors of lung and heart-lung transplantation. Am J Transplant. 2006 Sep;6(9):2157-63. doi: 10.1111/j.1600-6143.2006.01458.x. Epub 2006 Jul 6.