Does Early Postoperative Fluid Management Affect Functional Delayed Graft Function After Living Donor Kidney Transplantation?

February 11, 2026 updated by: Hatice Güneş Yeşilova, MD, Ankara University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Çankaya
      • Ankara, Çankaya, Turkey (Türkiye)
        • Ankara University Ibni Sina Research and Application Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Renal transplant recipients and donors aged 18 years and older
  • Renal transplant from a living donor

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
postoperatif 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kidney transplant function
Time Frame: Postoperative 1 year

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.
Postoperative 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Süheyla Karadağ Erkoç, Ankara University İbni Sina Research and Application Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RENALTRANSAÜTF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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