Short- and Long-Term Renal Outcomes Following Lung Transplantation

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046277
• Other study ID #: UGiessen
• Status: Completed
• Start date: March 22, 2017
• Est. completion date: August 24, 2019

Study information

• Verified date: February 2020
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 24, 2019
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Lung Transplantation

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg - Campus Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. Epub 2006 Jul 6. — View 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. — View 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 — View Citation

Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzì GM, De Rosa S, Muciño 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. — View Citation

Outcome

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