An interventional study of Sevoflurane General Anesthesia and Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia in Kidney Disease, End-Stage, Kidney Transplant and Kidney, sponsored by University of Gaziantep. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Basic science
Among 44 studies in Kidney Failure, Chronic with a site in Turkey — 9 open to participants now, 15 under way, 3 of them phase 3. Kidney Failure, Chronic · Turkey.
Among the 44 studies in Kidney Failure, Chronic with a site in Turkey, this one is the 19th largest by planned enrollment of the 29 interventional ones, is one of 4 that started in 2026, is one of 16 with no phase, reaches primary completion later than 6 of the 14 other live ones, and was the 40th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 68 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →9 of the 44 studies in Kidney Failure, Chronic with a site in Turkey are open now, in 12 countries. Each count lists the studies.
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 4 started in 2026.
Median enrollment 98 across the 29 interventional studies, 135 across the 15 observational. Of the 28 that completed or were terminated, 4 (14%) have results posted.
10 of 44 have an industry lead sponsor. The 10 most frequent:
University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
University of Gaziantep has 1 study filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
5 of the studies in Kidney Failure, Chronic with a site in Turkey that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT07685223Gazi UniversityMedium Cut-Off and High-Flux Membranes on Mineral and Bone Metabolism in Hemodialysis Patients | 2027-01 |
| NCT07679763Gazi UniversityRandomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes | 2027-01 |
| NCT06981585Izmir Democracy UniversityPhysical Impairments in Children With Chronic Renal Failure | 2027-03-01 |
| NCT07686978Gazi UniversityCardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls | 2027-07 |
Among the 44 studies in Kidney Failure, Chronic with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated.
This prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis.
The primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.
Renal transplantation represents the most effective form of renal replacement therapy for patients with end-stage renal disease; however, ischemia-reperfusion injury remains a major determinant of early graft dysfunction and long-term transplant outcomes.
Ferroptosis, an iron-dependent form of regulated cell death characterized by lipid peroxidation, has recently been proposed as an important mechanism contributing to ischemia-reperfusion-related tissue injury. In addition, mitochondrial-derived peptides such as humanin and MOTS-c have been identified as key regulators of cellular stress responses and may exert protective effects against oxidative damage. Despite these emerging findings, the influence of anesthetic technique on ferroptosis-related pathways and mitochondrial protective peptides in kidney transplantation has not yet been fully elucidated.
This prospective controlled study is designed to evaluate the effect of anesthetic technique on perioperative biochemical and clinical outcomes in renal transplant recipients. Adult patients undergoing kidney transplantation will receive either sevoflurane-based general anesthesia (SGA) or combined spinal-epidural anesthesia (CSEA). The two anesthetic strategies will be compared in terms of their effects on circulating ferroptosis-related biomarkers, as well as serum levels of humanin and MOTS-c.
Peripheral arterial blood samples will be obtained at two standardized points: immediately before anesthesia induction (T1) and immediately prior to extubation (T2). Following collection, blood samples will be centrifuged, and serum aliquots will be stored under appropriate conditions at -80°C until batch analysis. Serum levels of ferroptosis-related biomarkers, humanin, and MOTS-c will be measured using enzyme-linked immunosorbent assay (ELISA) and standard biochemical techniques.
The primary objective of the study is to assess the effect of anesthetic technique on perioperative changes in serum ferroptosis-related biomarkers and mitochondrial-derived peptides (humanin and MOTS-c).
The secondary objectives are to evaluate early postoperative graft function and clinical recovery parameters, including incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, and length of hospital stay. In addition, the association between perioperative biomarker levels and clinical outcomes will be analyzed to explore potential predictive relationships.
It is anticipated that this study will provide further insight into the relationship between anesthetic technique, ferroptosis pathways, and mitochondrial-mediated cytoprotection in renal transplantation. The results may contribute to improved understanding of perioperative biological responses and support optimization of anesthetic strategies aimed at enhancing graft outcomes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive sevoflurane general anesthesia according to standard institutional protocols for kidney transplantation.
Drug: Sevoflurane General Anesthesia
Participants in this group will receive combined spinal-epidural anesthesia as the anesthetic technique for kidney transplantation.
Drug: Bupivacaine and Morphine for Combined Spinal-Epidural Anesthesia
Participants will receive standardized sevoflurane general anesthesia according to institutional kidney transplantation protocols. Anesthesia induction will include preoxygenation with 100% oxygen for 3-5 minutes, followed by intravenous propofol (1.5-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium bromide (0.6 mg/kg). Endotracheal intubation will be performed after short mask ventilation using direct laryngoscopy, and correct placement will be confirmed by auscultation. Anesthesia maintenance will be provided with sevoflurane (1.5-2.0% end-tidal) in a 40-50% oxygen/air mixture and remifentanil infusion (0.05-0.2 µg/kg/min). Mechanical ventilation will be set to 6-8 mL/kg tidal volume, PEEP 5 cmH₂O, and end-tidal CO₂ 35-40 mmHg. At the end of surgery, sevoflurane will be discontinued, neuromuscular blockade will be reversed with sugammadex (2-4 mg/kg), and extubation will be performed after recovery. Postoperative analgesia will include subcutaneous morphine (0.1 mg/kg).
Also known as: Sevoflurane anesthesia
Participants will receive combined spinal-epidural anesthesia under sterile conditions according to institutional protocols. The L3-L4 interspace will be identified, and local anesthesia will be administered with lidocaine (2-3 mL, 2%). A Tuohy needle will be inserted using a midline approach, and the epidural space will be identified using loss-of-resistance technique. Spinal anesthesia will be achieved via intrathecal injection of 2.5 mL of 0.5% hyperbaric bupivacaine after confirmation of cerebrospinal fluid flow. An epidural catheter will then be placed and secured. Sedation will be provided with intravenous midazolam (1-2 mg), and oxygen will be administered via nasal cannula (4 L/min). Intraoperative analgesia will be maintained with epidural 0.25% bupivacaine as needed. At the end of surgery, epidural morphine (3 mg) combined with 0.25% bupivacaine will be administered for postoperative analgesia.
Also known as: CSE anesthesia
Serum ferroptosis-related biomarkers (Fe, TFRC1, GPX4, MDA, ACSL4) and mitochondrial-derived peptides (humanin and MOTS-c)
The primary outcome is the perioperative change in serum levels of ferroptosis-related biomarkers and mitochondrial-derived peptides, including humanin and MOTS-c, between two standardized time points. Blood samples will be collected immediately prior to anesthesia induction and immediately prior to extubation. Biomarker levels will be quantified using ELISA-based and standard biochemical methods. The primary comparison will evaluate differences in biomarker changes between the sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) groups.
Time frame: Immediately before anesthesia induction and immediately before extubation (intraoperative period)
Delayed Graft Function (DGF)
Delayed graft function will be defined as the requirement for dialysis within the first 7 postoperative days or a reduction in serum creatinine of less than 30% during the first 48 hours after transplantation. The incidence of delayed graft function will be compared between the study groups.
Time frame: Postoperative days 0-7
Postoperative Serum Creatinine Levels
Serial serum creatinine levels will be measured daily during the first postoperative week to evaluate early renal graft function and recovery.
Time frame: Postoperative days 1-7
Requirement for Postoperative Dialysis
The need for dialysis during the early post-transplant period will be recorded as a clinical indicator of graft dysfunction.
Time frame: Within first 7 postoperative days
Urine Output
Hourly urine output will be monitored to assess immediate graft perfusion and early functional recovery.
Time frame: Intraoperative period and first 24 postoperative hours
Length of Hospital Stay
Total duration of postoperative hospitalization will be recorded as a measure of overall recovery and clinical course.
Time frame: From surgery until discharge (up to 30 days)
Association Between Biomarkers and Clinical Outcomes
Correlation analyses will be performed to evaluate the relationship between perioperative biomarker levels (ferroptosis markers, humanin, and MOTS-c) and early clinical outcomes, including delayed graft function, serum creatinine levels, and urine output.
Time frame: Perioperative period and first 7 postoperative days
Plan to share: No — Individual participant data will not be publicly shared. Data may be available from the corresponding investigator upon reasonable request and after approval by the local ethics committee.
Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 7 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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