Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641622
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Study of the Correlation Between Donor CIRBP and Transplanted Kidney Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Correlation Between Donor CIRBP and Transplanted Kidney Function
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Deceased donors and recipients who successfully completed kidney transplantation between 2016 and 2019 were included in this study Donor plasma CIRBP levels were measured using an ELISA kit to evaluate their association with DGF incidence
Detailed Description:
The study was a retrospective open cohort study that included deceased patients from January 2016 to December 2019 It adhered to the guidelines of the National Program for Deceased Organ Donation in China and involved successful kidney donors from the Third Affiliated Hospital of Sun Yat-sen University Donors were excluded if they met any of the following conditions a lacked a blood specimen b had contaminated blood specimens affecting CIRBP levels c were recipients who underwent combined multi-organ transplants d were participating in other clinical trials e had a history of organ transplantation f had other conditions deemed unsuitable for enrollment by the investigator Blood specimens were collected from donors by Organ Procurement Organizations OPOs and used for various studies with the donors consent All recipients 207 recipients 207 donors were followed up in the long term after transplantation
The investigators followed the principles outlined in the Declaration of Helsinki 20 and the Declaration of Istanbul Approval for this study was obtained from the Human Organ Transplantation and Ethics Committee of Sun Yat-sen University The Ethics Committee was formed in compliance with the World Health Organizations Operational Guidelines for Ethics Committee Review of Biomedical Research Organ allocation was performed in a fair and transparent manner via the Chinese Organ Transplant Response System The type of donation was voluntarily determined by the donors family and the recipient underwent follow-up after transplantation Both the donors family and the recipient provided consent for the use of samples and clinical data in research
Donor data were obtained from the China Organ Transplant Response System completed by members of organ transplant organizations Additionally some donor information was supplemented from clinical electronic medical records Recipient data were derived from clinical electronic records alone Investigators categorized donors and recipients into delayed graft function DGF and immediate graft function IGF groups based on the recipients early renal function status DGF was defined as a decrease in daily plasma creatinine of less than 10 from the previous day for 3 consecutive days within 1 week postoperatively or if serum creatinine SCr did not decrease to 400 μmolL within 1 week after surgery Recipients who did not develop DGF were categorized as IGF Primary nonfunction PNF was diagnosed in patients requiring continuous dialysis after surgery or retransplantation Additionally expended criteria donors were defined as those aged over 60 years or between 50 and 59 years meeting at least two of the following criteria final serum creatinine 133 μmolL cerebrovascular accident as the cause of death and a history of hypertension
Sample Collection Whole blood specimens were obtained from the donor in the operating theater before organ retrieval and transported on crushed ice to the laboratory with an average transit duration of 2 hours For serum preparation the whole blood specimens were left at room temperature for 2 hours then centrifuged at 1000 g for 15 minutes at a temperature of 2-8C The resulting supernatant was collected and stored at -80C within the laboratory Before testing the serum samples were thawed on crushed ice and centrifuged again at 1000 g for 15 minutes at 2-8C
Measurement Of Cold Inducible RNA Binding Protein Level Serum CIRBP was detected using an ELISA kit CSB-EL005440HU The protein standard was diluted according to the instructions and 100 µl of different concentrations of standard and samples 110 dilution were added to a 96-well plate in duplicate The plate was incubated at 37C for 2 hours in the dark Following incubation the liquid in the wells was discarded and 100 µl of biotin-labeled antibody working solution was added to each well After incubating at 37C for 1 hour the plate was washed three times with washing solution Subsequently 100 µl of horseradish peroxidase-labeled affinity solution was added to each well After an additional 1-hour incubation at 37C the plate was washed five times Then 90 µl of substrate solution was added to each well and after a 15-minute color development at 37C 50 µl of termination solution was used to stop the reaction The absorbance was measured at 450 nm within 5 minutes using a microplate reader and concentrations were calculated based on the standard curve
The investigators followed the principles outlined in the Declaration of Helsinki 20 and the Declaration of Istanbul Approval for this study was obtained from the Human Organ Transplantation and Ethics Committee of Sun Yat-sen University The Ethics Committee was formed in compliance with the World Health Organizations Operational Guidelines for Ethics Committee Review of Biomedical Research Organ allocation was performed in a fair and transparent manner via the Chinese Organ Transplant Response System The type of donation was voluntarily determined by the donors family and the recipient underwent follow-up after transplantation Both the donors family and the recipient provided consent for the use of samples and clinical data in research
Donor data were obtained from the China Organ Transplant Response System completed by members of organ transplant organizations Additionally some donor information was supplemented from clinical electronic medical records Recipient data were derived from clinical electronic records alone Investigators categorized donors and recipients into delayed graft function DGF and immediate graft function IGF groups based on the recipients early renal function status DGF was defined as a decrease in daily plasma creatinine of less than 10 from the previous day for 3 consecutive days within 1 week postoperatively or if serum creatinine SCr did not decrease to 400 μmolL within 1 week after surgery Recipients who did not develop DGF were categorized as IGF Primary nonfunction PNF was diagnosed in patients requiring continuous dialysis after surgery or retransplantation Additionally expended criteria donors were defined as those aged over 60 years or between 50 and 59 years meeting at least two of the following criteria final serum creatinine 133 μmolL cerebrovascular accident as the cause of death and a history of hypertension
Sample Collection Whole blood specimens were obtained from the donor in the operating theater before organ retrieval and transported on crushed ice to the laboratory with an average transit duration of 2 hours For serum preparation the whole blood specimens were left at room temperature for 2 hours then centrifuged at 1000 g for 15 minutes at a temperature of 2-8C The resulting supernatant was collected and stored at -80C within the laboratory Before testing the serum samples were thawed on crushed ice and centrifuged again at 1000 g for 15 minutes at 2-8C
Measurement Of Cold Inducible RNA Binding Protein Level Serum CIRBP was detected using an ELISA kit CSB-EL005440HU The protein standard was diluted according to the instructions and 100 µl of different concentrations of standard and samples 110 dilution were added to a 96-well plate in duplicate The plate was incubated at 37C for 2 hours in the dark Following incubation the liquid in the wells was discarded and 100 µl of biotin-labeled antibody working solution was added to each well After incubating at 37C for 1 hour the plate was washed three times with washing solution Subsequently 100 µl of horseradish peroxidase-labeled affinity solution was added to each well After an additional 1-hour incubation at 37C the plate was washed five times Then 90 µl of substrate solution was added to each well and after a 15-minute color development at 37C 50 µl of termination solution was used to stop the reaction The absorbance was measured at 450 nm within 5 minutes using a microplate reader and concentrations were calculated based on the standard curve
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None