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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Lundbeck Foundation | OTHER |
| Novo Nordisk A/S | INDUSTRY |
| AP Moeller Foundation |
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The purpose of this study is to determine whether remote ischemic conditioning can improve the outcome after renal transplantation with deceased donor. Remote ischemic conditioning is performed on the patient receiving a kidney from a deceased donor. Remote ischemic conditioning is done during the operation by inflating a tourniquet on the patients leg before opening the blood circulation to the kidney. The study focus on both the immediate kidney function after the transplantation, but also on the extended kidney function one year after the transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non remote ischemic conditionin(non-rIC) | No Intervention | Patients receiving kidney transplantation from a deceased donor. This group does not receive remote ischemic conditioning, but has a tourniquet on the leg (not inflated). | |
| Remote ischemic conditioning (rIC) | Experimental | Patients receiving kidney transplantation from a deceased donor. This group receives remote ischemic conditioning by inflating a tourniquet on the leg during surgery, before reperfusion of the kidney. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Other | Patients receiving kidney transplantation from a deceased donor. Remote ischemic conditioning (rIC) is done by inflating a tourniquet (250mmHg) on the patients leg before reperfusion of the kidney. The tourniquet stays on the leg on the opposite site of were the kidney is placed. rIC is done 4 x 5 min with 5 min intervals between with free blood flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to a 50% drop in baseline plasma-creatinine | Plasma-creatinine changes posttransplant will be described using an exponential/logistic/linear model depending on the individual patient data. All plasma-creatinine values 30 days posttransplant, or in case of temporary posttransplant dialysis 30 days after the last performed dialysis, will be used, measured minimum twice daily initially. Baseline plasma-creatinine is measured approximately 1 hour prior to reperfusion of the kidney. Time to a 50% drop in baseline plasma-creatinine will be estimated. | minimum 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Need for dialysis | 1 week | |
| GFR after 1 year | GFR measurement by Cr-EDTA. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoline V Krogstrup, MD | Klinisk Institut, Aarhus University | Principal Investigator |
| Bente Jespersen, Professor, DMSc, MD | Klinisk Institut, Aarhus University | Study Chair |
| Henrik Birn, DMSc, MD | University of Aarhus | Study Chair |
| Mihai Oltean, MD, PhD | Sahlgrenska University Hospital | Study Chair |
| Gertrude J. Nieuwenhuijs-Moeke, MD | University Medical Center Groningen | Study Chair |
| Frank J. M. F. Dor, MD, PhD | Erasmus Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Renal Medicine, Aarhus University Hospital, Skejby | Aarhus N | 8200 | Denmark | |||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473350 | Derived | Nielsen MB, Ravlo K, Eijken M, Krogstrup NV, Bue Svendsen M, Abdel-Halim C, Steen Petersen M, Birn H, Oltean M, Jespersen B, Moller BK. Dynamics of circulating dendritic cells and cytokines after kidney transplantation-No effect of remote ischaemic conditioning. Clin Exp Immunol. 2021 Nov;206(2):226-236. doi: 10.1111/cei.13658. Epub 2021 Sep 29. | |
| 34379701 |
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| OTHER |
| Danish Society of Nephrology | OTHER |
| Aarhus University Hospital | OTHER |
| Erasmus Medical Center | OTHER |
| University Medical Center Groningen | OTHER |
| Danish Council for Independent Research | OTHER |
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|
|
| Groningen |
| Provincie Groningen |
| 9713 GZ |
| Netherlands |
| Division of Transplant Surgery, Erasmus MC, University Medical Center | Rotterdam | Rotterdam | 3000 CA | Netherlands |
| Sahlgrenska Transplant Institute, Sahlgrenska Academy at the University of Gothenborg | Gothenburg | 413 45 | Sweden |
| Nielsen MB, Jespersen B, Birn H, Krogstrup NV, Bourgonje AR, Leuvenink HGD, van Goor H, Norregaard R. Elevated plasma free thiols are associated with early and one-year graft function in renal transplant recipients. PLoS One. 2021 Aug 11;16(8):e0255930. doi: 10.1371/journal.pone.0255930. eCollection 2021. |
| 31887168 | Derived | Nielsen MB, Krogstrup NV, Oltean M, Nieuwenhuijs-Moeke GJ, Dor FJMF, Birn H, Jespersen B. Remote ischaemic conditioning and early changes in plasma creatinine as markers of one year kidney graft function-A follow-up of the CONTEXT study. PLoS One. 2019 Dec 30;14(12):e0226882. doi: 10.1371/journal.pone.0226882. eCollection 2019. |
| 30817778 | Derived | Nielsen MB, Krogstrup NV, Nieuwenhuijs-Moeke GJ, Oltean M, Dor FJMF, Jespersen B, Birn H. P-NGAL Day 1 predicts early but not one year graft function following deceased donor kidney transplantation - The CONTEXT study. PLoS One. 2019 Feb 28;14(2):e0212676. doi: 10.1371/journal.pone.0212676. eCollection 2019. |
| 27696662 | Derived | Krogstrup NV, Oltean M, Nieuwenhuijs-Moeke GJ, Dor FJ, Moldrup U, Krag SP, Bibby BM, Birn H, Jespersen B. Remote Ischemic Conditioning on Recipients of Deceased Renal Transplants Does Not Improve Early Graft Function: A Multicenter Randomized, Controlled Clinical Trial. Am J Transplant. 2017 Apr;17(4):1042-1049. doi: 10.1111/ajt.14075. Epub 2016 Nov 9. |
| 26297360 | Derived | Krogstrup NV, Oltean M, Bibby BM, Nieuwenhuijs-Moeke GJ, Dor FJ, Birn H, Jespersen B. Remote ischaemic conditioning on recipients of deceased renal transplants, effect on immediate and extended kidney graft function: a multicentre, randomised controlled trial protocol (CONTEXT). BMJ Open. 2015 Aug 20;5(8):e007941. doi: 10.1136/bmjopen-2015-007941. |
| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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