Renal TransplantNCT07392996
Does Early Postoperative Fluid Management Affect Functional Delayed Graft Function After Living Donor Kidney Transplantation?
An observational study of Renal Transplant and DGF, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Fluid management in renal transplantation is of critical importance for optimizing graft function and minimizing complications such as delayed graft function (DGF) and acute kidney injury (AKI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant, DGF
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Between 2017 and 2025, 122 patients who met the inclusion criteria for the study were enrolled from among recipients and donors of living donor renal transplants performed in the General Surgery operating theatre at Ankara University İbni Sina Research and Application Hospital.
Who may be able to join
- Renal transplant recipients and donors aged 18 years and older
- Renal transplant from a living donor
Who cannot join
- Patients under 18 years of age
- Patients with incomplete or missing medical records
- Patients with heart disease (ejection fraction < 30)
- Multiple organ transplant
- History of repeated kidney transplants
- Cadaveric renal transplant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University İbni Sina Research and Application Hospital
Ankara, Çankaya
About this study
Official title: Does Early Postoperative Fluid Management Affect Functional Delayed Graft Function After Living Donor Kidney Transplantation? A Retrospective Cohort Analysis
Fluid management in renal transplantation is of critical importance for optimizing graft function and minimizing complications such as delayed graft function (DGF) and acute kidney injury (AKI). The aim of this study was to retrospectively investigate the effects of early postoperative (the first 4 hours after transplantation) fluid replacement volume on graft function in patients undergoing living donor kidney transplantation.
Read the detailed description
Maintaining an appropriate fluid balance is of paramount importance in renal transplantation. Overhydration may lead to complications such as pulmonary edema and impaired renal perfusion, whereas insufficient hydration can result in hypoperfusion and acute kidney injury (AKI). The amount of fluid administered in conjunction with goal-directed hemodynamic management plays a crucial role in improving kidney transplant outcomes. By carefully balancing fluid therapy and monitoring hemodynamic parameters, graft function can be improved and postoperative complications can be reduced.
Delayed graft function (DGF) is a term used instead of post-transplant acute renal failure and is broadly defined as the need for dialysis within the first week after transplantation. It is well known that DGF increases susceptibility to acute rejection. Implementing interventions before irreversible injury occurs represents the most effective strategy for reducing DGF. Fluid therapy has been shown to be effective in preventing AKI in selected patient populations.
Several factors predispose kidney transplant recipients to hypotension, including the sudden redistribution of approximately 25% of the cardiac output to the renal graft following revascularization, the release of vasoactive mediators accumulated during ischemia with the associated risk of post-reperfusion syndrome, and cytokine-mediated hypotension related to immunosuppressive agents administered shortly before vascular unclamping. In addition, the transplanted kidney is denervated and lacks neurogenic regulation of renal blood flow. Consequently, renal perfusion becomes more dependent on intravascular volume status and arterial blood pressure. Every effort should therefore be made to maintain adequate arterial blood pressure, primarily through sufficient intravascular volume and secondarily through the judicious use of vasopressors when necessary.
Despite improvements in overall outcomes among kidney transplant recipients, delayed graft function remains a significant complication and an important predictor of subsequent clinical outcomes. DGF is associated with reduced graft and patient survival, long-term graft dysfunction, and an increased incidence of acute rejection. Optimized perioperative hemodynamic management has been shown to be effective in preventing DGF and reducing perioperative complications; however, the optimal strategy for fluid therapy remains controversial.
Kidney transplant recipients are at risk for developing DGF, AKI, and fluid overload. Hypovolemia may exacerbate renal injury, whereas excessive fluid administration may result in pulmonary edema.
Previous studies investigating optimal fluid replacement strategies have focused on targeting central venous pressure (CVP), restrictive fluid regimens or goal-directed fluid therapy, and the timing of fluid administration; however, no consistent conclusions have been reached.
One study evaluating the effects of a restrictive fluid regimen demonstrated an approximately fourfold increase in the risk of DGF. Another study showed that patients who received the largest volume of fluid immediately before renal artery unclamping exhibited lower hemodynamic instability and higher systolic blood pressure, mean arterial pressure, and central venous pressure levels. In contrast, a retrospective study examining goal-directed fluid replacement reported adverse effects on clinical outcomes ; however, these findings are inconsistent with other studies investigating goal-directed fluid therapy.
Optimizing fluid management in renal transplantation remains a critical component of improving patient outcomes and ensuring long-term graft success. In our clinical practice, we aim to investigate the effects of early postoperative fluid replacement volumes on graft function and patient outcomes, with the goal of contributing to improved clinical practices and better long-term outcomes for transplant recipients.
- Conditions
- Renal Transplant, DGF
- Keywords
- Kidney transplantation, fDGF, fluid replacement, living organ donor
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Delayed Graft Function (fDGF)
Functional delayed graft function (fDGF) was defined as the absence of a spontaneous daily decrease of at least 10% in serum creatinine levels for three consecutive days during the first postoperative week. To avoid misclassification in patients with excellent early graft function, a lack of creatinine decline on postoperative day 3 was not classified as fDGF if optimal graft function had already been achieved by postoperative day 2.
Measured: postoperatif 7 days
Secondary outcomes (1)
Kidney transplant function
Graft dysfunction was defined as either the development of a need for hemodialysis or the presence of chronic allograft dysfunction, both occurring within the first postoperative year.
Chronic allograft dysfunction (CKD-T) was defined as persistent graft dysfunction lasting for at least 3 months, characterized by an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² and/or evidence of structural kidney damage in kidney transplant recipients.
Measured: Postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Sep 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Güneş Yeşilova, MD, Ankara University
- Investigators
- Süheyla Karadağ Erkoç, Study director, Ankara University İbni Sina Research and Application Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392996
- Sponsor's protocol ID
- RENALTRANSAÜTF
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Postoperative Fluid Management Affect Functional Delayed Graft Function After Living Donor Kidney Transplantation? A Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT07392996
- Acronym / sponsor ID
- RENALTRANSAÜTF
- Conditions
- Renal Transplant, DGF
- Keywords
- Kidney transplantation, fDGF, fluid replacement, living organ donor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- 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.
Fluid management in renal transplantation is of critical importance for optimizing graft function and minimizing complications such as delayed graft function (DGF) and acute kidney injury (AKI). The aim of this study was to retrospectively investigate the effects of early postoperative (the first 4 hours after transplantation) fluid replacement volume on graft function in patients undergoing living donor kidney transplantation.
Detailed description
Maintaining an appropriate fluid balance is of paramount importance in renal transplantation. Overhydration may lead to complications such as pulmonary edema and impaired renal perfusion, whereas insufficient hydration can result in hypoperfusion and acute kidney injury (AKI). The amount of fluid administered in conjunction with goal-directed hemodynamic management plays a crucial role in improving kidney transplant outcomes. By carefully balancing fluid therapy and monitoring hemodynamic parameters, graft function can be improved and postoperative complications can be reduced.
Delayed graft function (DGF) is a term used instead of post-transplant acute renal failure and is broadly defined as the need for dialysis within the first week after transplantation. It is well known that DGF increases susceptibility to acute rejection. Implementing interventions before irreversible injury occurs represents the most effective strategy for reducing DGF. Fluid therapy has been shown to be effective in preventing AKI in selected patient populations.
Several factors predispose kidney transplant recipients to hypotension, including the sudden redistribution of approximately 25% of the cardiac output to the renal graft following revascularization, the release of vasoactive mediators accumulated during ischemia with the associated risk of post-reperfusion syndrome, and cytokine-mediated hypotension related to immunosuppressive agents administered shortly before vascular unclamping. In addition, the transplanted kidney is denervated and lacks neurogenic regulation of renal blood flow. Consequently, renal perfusion becomes more dependent on intravascular volume status and arterial blood pressure. Every effort should therefore be made to maintain adequate arterial blood pressure, primarily through sufficient intravascular volume and secondarily through the judicious use of vasopressors when necessary.
Despite improvements in overall outcomes among kidney transplant recipients, delayed graft function remains a significant complication and an important predictor of subsequent clinical outcomes. DGF is associated with reduced graft and patient survival, long-term graft dysfunction, and an increased incidence of acute rejection. Optimized perioperative hemodynamic management has been shown to be effective in preventing DGF and reducing perioperative complications; however, the optimal strategy for fluid therapy remains controversial.
Kidney transplant recipients are at risk for developing DGF, AKI, and fluid overload. Hypovolemia may exacerbate renal injury, whereas excessive fluid administration may result in pulmonary edema.
Previous studies investigating optimal fluid replacement strategies have focused on targeting central venous pressure (CVP), restrictive fluid regimens or goal-directed fluid therapy, and the timing of fluid administration; however, no consistent conclusions have been reached.
One study evaluating the effects of a restrictive fluid regimen demonstrated an approximately fourfold increase in the risk of DGF. Another study showed that patients who received the largest volume of fluid immediately before renal artery unclamping exhibited lower hemodynamic instability and higher systolic blood pressure, mean arterial pressure, and central venous pressure levels. In contrast, a retrospective study examining goal-directed fluid replacement reported adverse effects on clinical outcomes ; however, these findings are inconsistent with other studies investigating goal-directed fluid therapy.
Optimizing fluid management in renal transplantation remains a critical component of improving patient outcomes and ensuring long-term graft success. In our clinical practice, we aim to investigate the effects of early postoperative fluid replacement volumes on graft function and patient outcomes, with the goal of contributing to improved clinical practices and better long-term outcomes for transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between 2017 and 2025, 122 patients who met the inclusion criteria for the study were enrolled from among recipients and donors of living donor renal transplants performed in the General Surgery operating theatre at Ankara University İbni Sina Research and Application Hospital.
Key inclusion criteria (2 listed)
- Renal transplant recipients and donors aged 18 years and older
- Renal transplant from a living donor
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Patients with incomplete or missing medical records
- Patients with heart disease (ejection fraction < 30)
- Multiple organ transplant
- History of repeated kidney transplants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Delayed Graft Function (fDGF)
Time frame: postoperatif 7 days
Functional delayed graft function (fDGF) was defined as the absence of a spontaneous daily decrease of at least 10% in serum creatinine levels for three consecutive days during the first postoperative week. To avoid misclassification in patients with excellent early graft function, a lack of creatinine decline on postoperative day 3 was not classified as fDGF if optimal graft function had already been achieved by postoperative day 2.
1 secondary outcome
Kidney transplant function
Time frame: Postoperative 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Süheyla Karadağ Erkoç study director
Ankara University İbni Sina Research and Application Hospital.
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 Renal Transplant and DGF, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Functional Delayed Graft Function (fDGF) (time frame: postoperatif 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.