Short- and Long-Term Renal Outcomes Following Lung Transplantation

Completed

• Conditions: Acute Kidney Injury; Lung Transplantation
• Interventions: Other: No intervention

• Registration Number: NCT03046277
• Lead Sponsor: University of Giessen

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.

Study Timeline

• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-04
• Study First Posted: 2017-02-08
• Study Start: 2017-03-22
• Primary Completion: 2019-08-24
• Study Completion: 2019-08-24
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing LTx	No intervention	Retrospective analysis of clinical data
Patients with pretransplant renal functional reserve testing	No intervention	Prospective analysis of clinical data

Primary Outcome Measures

Name	Time	Method
Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.	7 days	AKI defined by KDIGO consensus criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Giessen, Hessen, Germany