- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907434
Cell Cycle Arrest Proteins for Early Diagnosis of Acute Kidney Injury After Lung Transplant (LUTX_AKI)
Cell Cycle Arrest Proteins for Early Diagnosis of Acute Kidney Injury After Lung Transplant: a Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bilateral lung transplantation (LUTX) is a surgical procedure offered to patients suffering from chronic respiratory failure. LUTX provides a survival benefit to selected patients but is associated with several short-term and long-term non-pulmonary complications. Acute kidney failure (AKI) is frequent and associated with short-term and long-term morbidity and increased mortality. Indeed, AKI occurs in up to two-thirds of transplanted patients, with 5-13% needing renal replacement therapy (RRT), and associated with mortality ranging from 13 to 50%.
Several risk factors may favor postoperative AKI in patients undergoing LUTX: preoperative (e.g., the patients' preoperative renal function and comorbidities) , intraoperative (i.e., hypoxia, hypotension, massive blood components' transfusions, use of intraoperative extracorporeal membrane oxygenation - ECMO) and postoperative (i.e., use of nephrotoxic agents as tacrolimus and antibiotics).
In patients treated with LUTX, postoperative AKI increases ICU and hospital length of stay and is associated with worsened survival10. At the same time, postoperative AKI is associated with an increase in end-stage renal failure and consequent chronic renal failure11 with potential needs of chronic RRT. Finally, AKI may determine primary graft disfunction with direct and indirect mechanisms (i.e., inability to reach therapeutic targets of anti-rejection drugs).
According to the most recent guidelines (i.e., the Kidney Improving Global Outcomes (KDIGO) criteria), patients are classified as suppering postoperative AKI stage 1, stage 2, and stage 3 are diagnosed whether serum creatinine increases 1.5-1.9 times, 2-2.9 times, and >3 times from the preoperative, respectively. However, these traditional indicators of kidney function have limitations related to early and accurate identification of AKI. Furthermore, sCr has limitations in the specific context of LUTX, both regarding baseline patients' clinical characteristics and surgical. On the one hand, patients enlisted for LUTX are usually undernourished, have reduced muscle mass, reduced protein and creatine intake, which severely limit the sensibility and sensitivity of sCr changes for AKI diagnosis. On the other hand, the need for massive fluid and blood products during LUTX resulting in fluid overload can mask the increase in sCr, delaying the diagnosis of AKI. In addition, early detection of AKI using sCr concentrations is limited by the fact that sCr concentrations increase when renal function has already deteriorated15.
Thus, novel markers capable of early and effective diagnosis of AKI in this patient population are a major clinical interest and may allow to carry out risk-mitigating clinical approaches (e.g., volume optimization, avoid nephrotoxic agents).
Cell Cycle arrest proteins have been suggested as early indicators of AKI. In particular, urinary tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7) are biomarkers of the renal tubular cell cycle arrest at the early phase of AKI. The product of the urinary concentrations of TIMP-2 and IGFBP-7 (urinary [TIMP- 2] × [IGFBP-7]) is a promising biomarker for early prediction of AKI in various clinical settings such as out-of-hospital cardiac arrest, in critically ill patients, and following major surgery or emergency department admission .
It is possible to envision the employment of the urinary [TIMP- 2] × [IGFBP-7] index as early indicators of renal failure in patients undergoing LUTX. Thus, with this prospective observational study, the aim of the study is to test the sensitivity and specificity of this index in detecting early AKI in patients undergone LUTX.
Hypothesis/objectives of the study:
In patients undergoing LUTX, the urinary biomarker [TIMP-2] × [IGFBP-7] measured on the first postoperative day after LUTX was evaluated as a reliable early predictive index of postoperative AKI compared to standard KIDGO criteria.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Milan, Italy, 20122
- Recruiting
- Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
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Principal Investigator:
- Vittorio Scaravilli, MD
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Contact:
- Vittorio Scaravilli, MD
- Phone Number: 0255033275
- Email: vittorio.scaravilli@unimi.it
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Contact:
- giacomo grasselli
- Phone Number: 0255033275
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Enlistment for bilateral LUTX
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
- Age < 18 years old
- Urgency enlistment
- Already undergone LUTX
- Preoperative use of RRT
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute kidney injury
Time Frame: <7 days from lung transplant
|
according to KIDGO guidelines
|
<7 days from lung transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute kidney disease
Time Frame: < 90 days from lung transplant
|
according to KIDGO guidelines
|
< 90 days from lung transplant
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 127_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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