Lung TransplantationNCT03046277
Short- and Long-Term Renal Outcomes Following Lung Transplantation
An observational study of Lung Transplantation and Acute Kidney Injury, run by University of Giessen at 1 site in Germany.
Trial summary
Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease in patients undergoing lung transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation, Acute Kidney Injury
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 22 Mar 2017to 24 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Older than 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, 35392
About this study
Official title: Short- and Long-Term Renal Outcomes Following Lung Transplantation- A Single-Centre Experience
Evaluation of acute kidney injury, renal recovery and development of chronic kidney disease in patients undergoing lung transplantation
Read the 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.
- Conditions
- Lung Transplantation, Acute Kidney Injury
- Being tested
- No intervention
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing LTx | Retrospective analysis of clinical data Receives: Other: No intervention | |
| Patients with pretransplant renal functional reserve testing | Prospective analysis of clinical data Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.
AKI defined by KDIGO consensus criteria
Measured: 7 days
Secondary outcomes (5)
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
Measured: 3 years
Risk factors associated with development of AKI and CKD after lung transplantation
AKI and CKD defined by KDIGO consensus criteria
Measured: 3 years
Whether development of CKD is an independent risk factor for increased rejection rate and death after lung transplantation.
CKD defined by KDIGO consensus criteria
Measured: 3 years
Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation.
AKI defined by KDIGO consensus criteria
Measured: 7 days
Association between pretransplant renal functional reserve and renal function loss after lung transplantation.
24h-creatinine clearance, estimated glomerular filtration rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start22 Mar 2017
- Primary completion24 Aug 2019
- Study completion24 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faeq Husain, University of Giessen
- Investigators
- Werner Seeger, MD, Study director, University Hospital Giessen and Marburg, Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046277
- Sponsor's protocol ID
- UGiessen
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29382510Fidalgo 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.
PubMed 24957809Fidalgo 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.
PubMed 25138690Canales 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.
PubMed 16827787Kuhnert 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.
PubMed 39282762
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-Term Renal Outcomes Following Lung Transplantation- A Single-Centre Experience
- ClinicalTrials.gov ID
- NCT03046277
- Acronym / sponsor ID
- UGiessen
- Conditions
- Lung Transplantation, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 24 Aug 2019 (actual)
- Study completion
- 24 Aug 2019 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing LTx | – | Other: No interventionRetrospective analysis of clinical data |
| Patients with pretransplant renal functional reserve testing | – | Other: No interventionProspective analysis of clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Older than 18 years
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients undergoing LTx, Patients with pretransplant renal functional reserve testing |
Primary outcome
Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline.
Time frame: 7 days
AKI defined by KDIGO consensus criteria
5 secondary outcomes
Impact of sustained reversal versus non-recovery after AKI on long-term renal function decline after lung transplantation.
Time frame: 3 years
Risk factors associated with development of AKI and CKD after lung transplantation
Time frame: 3 years
Whether development of CKD is an independent risk factor for increased rejection rate and death after lung transplantation.
Time frame: 3 years
Association between pretransplant renal functional reserve with acute kidney injury after after lung transplantation.
Time frame: 7 days
Association between pretransplant renal functional reserve and renal function loss after lung transplantation.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 29382510Husain-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.
- Results publication: PubMed 24957809Fidalgo 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.
- Results publication: PubMed 25138690Fidalgo 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.
- Results publication: PubMed 16827787Canales 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.
- Derived from this study: PubMed 39282762Kuhnert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Seeger, MD study director
University Hospital Giessen and Marburg, Giessen, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation and Acute Kidney Injury, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of acute kidney injury (AKI) after lung transplantation on long-term renal function decline. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046277, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.