Short- and Long-Term Renal Outcomes Following Lung Transplantation

• Sponsor: University of Giessen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03046277
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Actual Duration (Months): 29.1
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation; Acute Kidney Injury	Other: No intervention

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 Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Short- and Long-Term Renal Outcomes Following Lung Transplantation- A Single-Centre Experience
• Actual Study Start Date: Mar 22, 2017
• Actual Primary Completion Date: Aug 24, 2019
• Actual Study Completion Date: Aug 24, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Risk factors associated with development of AKI and CKD after lung transplantation [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. [3 years]

   CKD defined by KDIGO consensus criteria

4. Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation. [7 days]

   AKI defined by KDIGO consensus criteria

5. Association between pretransplant renal functional reserve and renal function loss after lung transplantation. [1 year]

   24h-creatinine clearance, estimated glomerular filtration rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Clinic Giessen and Marburg - Campus Giessen	Giessen	Hessen	Germany	35392

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
• ClinicalTrials.gov Identifier: NCT03046277
• Other Study ID Numbers: UGiessen
• First Posted: Feb 8, 2017
• Last Update Posted: Feb 5, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Feb 5, 2020