Short- and Long-Term Renal Outcomes Following Lung Transplantation

NCT03046277 | Completed

• 1 other identifier: UGiessen
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplantation; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.

  AKI defined by KDIGO consensus criteria

  7 days

Secondary Outcomes (5)

• Impact of sustained reversal versus non-recovery after AKI on long-term renal function decline after lung transplantation.

  3 years

• Risk factors associated with development of AKI and CKD after lung transplantation

  3 years

• Whether development of CKD is an independent risk factor for increased rejection rate and death after lung transplantation.

  3 years

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

  7 days

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

  1 year

Study Arms (2)

Patients undergoing LTx

Retrospective analysis of clinical data

Other: No intervention

Patients with pretransplant renal functional reserve testing

Prospective analysis of clinical data

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients undergoing LTx; Patients with pretransplant renal functional reserve testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Older than 18 years

You may not qualify if:

• 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
• as above
• unable to perform renal functional reserve testing (e.g., due to critical illness)
• pre-existing acute kidney injury

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (5)

• 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.

  PMID: 29382510 BACKGROUND

• 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.

  PMID: 24957809 RESULT

• 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.

  PMID: 25138690 RESULT

• 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.

  PMID: 16827787 RESULT

• Kuhnert S, Sommerlad J, Gall H, Weder MM, Wolff M, Eberle S, Sander M, Reichert M, Koch C, Askevold I, Hecker A, Padberg W, Ostermann M, Mehta R, Ronco C, Birk HW, Seeger W, Mayer K, Hecker M, Husain-Syed F. Postoperative Fluid Accumulation is Associated With Underestimation of AKI Severity in Lung Transplant Recipients. Clin Transplant. 2024 Sep;38(9):e15457. doi: 10.1111/ctr.15457.

  PMID: 39282762 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Collection of only residual material (blood, urine) was done for Deutsche Zentrum für Lungenforschung Biobank.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Werner Seeger, MD

  University Hospital Giessen and Marburg, Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician Nephrology

Study Record Dates

• First Submitted: February 4, 2017
• First Posted: February 8, 2017
• Study Start: March 22, 2017
• Primary Completion: August 24, 2019
• Study Completion: August 24, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)