Delayed Graft FunctionNCT06367205
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
A study testing Goal-Directed Fluid Therapy (GDFT) and Regular Fluid Therapy in people with Delayed Graft Function and End Stage Renal Disease, run by RenJi Hospital at 3 sites in China.
Trial summary
Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, End Stage Renal Disease, Kidney Transplantation
- What is being tested?
- Goal-Directed Fluid Therapy (GDFT) and Regular Fluid Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Recipients aged 18 years or older
- Scheduled to undergo kidney transplantations under general anesthesia
- Cadaveric kidney transplantations
- Sign the informed consent form
Who cannot join
- Donors aged under 18 years
- Donor kidneys classified as Maastricht category I or II
- Contraindications to radial artery catheterization
- Pregnancy
- Cardiac dysfunction (exercise tolerance less than 4 METS)
- Severe liver dysfunction (Child Pugh C-grade)
Show all 13Show fewer
- Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
- Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
- Double-kidney transplantations
- Simultaneous organ or additional surgeries during kidney transplantations
- Repeat kidney transplantations
- Concurrent participation in other clinical trials
- Patients deemed ineligible by researchers
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Muyan Shi, B.S., +862168383702, jsqdsmy@163.com
- Not yet recruiting
General Hospital of Northern Theatre Command
Shenyang, Liaoning, 110016
Yugang Diao, Dr.
- Not yet recruiting
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Jianjun Yang, Dr.
About this study
Official title: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial
Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.
Read the detailed description
Chronic kidney disease (CKD) presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end stage renal disease (ESRD), markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function (DGF) represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of DGF can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of DGF. Recent strides in goal-directed fluid therapy (GDFT) have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of GDFT specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of DGF in this patient demographic.
- Being tested
- Goal-Directed Fluid Therapy (GDFT), Regular Fluid Therapy
- Keywords
- Norepinephrine, Goal-directed fluid therapy, Randomized controlled trial
- Medical subject headings
- Delayed Graft Function, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Fluid Therapy (GDFT)Drug
Also called GDFT
Norepinephrine will be administered intravenously at a rate of 0.06 µg/kg/min, followed by the implementation of fluid therapy guided by SVV until reaching our target. In instances where SVV ≤ 13%, indicative of adequate effective circulating blood volume, the fluid infusion rate will be adjusted to 1 ml/kg/h. Conversely, if SVV > 13%, denoting inadequate effective circulating blood volume, a rapid infusion of 1 ml/kg of crystalloid fluid will be administered over 2 minutes, with subsequent observation of fluid reactivity after a further 2-minute interval. This process is reiterated until SVV ≤ 13% is attained. Should SVV > 13% recurs during surgery, the aforementioned intervention is repeated.
Regular Fluid TherapyDrug
Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary
| Study group | Role | What they receive |
|---|---|---|
| Goal-Directed Fluid Therapy (GDFT) group | Experimental | Following anesthesia induction, patients will be connected to the FlowTrac/Vigileo monitoring system to facilitate the recording of pertinent hemodynamic parameters, including stroke volume variation (SVV), stroke volume, and cardiac output. Then, Norepinephrine Infusion Combined with Goal-directed Fluid Therapy will be administered. Efforts are made to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg. Receives: Drug: Goal-Directed Fluid Therapy (GDFT) |
| Regular Fluid Therapy group | Active comparator | Patients will not undergo monitoring with the FlowTrac/Vigileo system throughout the whole procedure. Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg until the conclusion of the surgical procedure. Receives: Drug: Regular Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of delayed graft function (DGF)
The need for dialytic intervention within the initial week post-transplantation
Measured: Patients will be followed from postoperative day 1 to 7.
Secondary outcomes (7)
The area under the curve of serum creatinine levels from postoperative day 1 to 7
The area under the curve of serum creatinine levels from postoperative day 1 to 7
Measured: Patients will be followed from postoperative day 1 to 7.
Duration of DGF
The interval from surgery completion to the last dialysis up to 84 days post-surgery
Measured: Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.
Number of dialysis sessions during postoperative hospitalization
Number of dialysis sessions during postoperative hospitalization
Measured: Patients will be followed from surgery completion to discharge，an average of 20 days.
Total urine output on the second postoperative day
Total urine output on the second postoperative day
Measured: Patients will be followed on the second postoperative day.
Duration of intensive care unit (ICU) stay
Duration of intensive care unit (ICU) stay
Measured: Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.
Length of hospitalization
Length of hospitalization
Measured: Patients will be followed from hospitalization to discharge, an average of 20 days.
Incidence of readmission within 30 days post-discharge
Incidence of readmission within 30 days post-discharge
Measured: Patients will be followed from discharge to 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Dr., Principal investigator, Department of Anesthesiology Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367205
- Sponsor's protocol ID
- LY2023-135-A
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi M, Zhang Y, Ding X, Cheng X, Zhou J, Su D. The effects of norepinephrine infusion combined with goal-directed fluid therapy on delayed graft function in patients undergoing kidney transplantations: study protocol for a multicenter randomized controlled trial. Trials. 2026 Aug 29;27(1):559. doi: 10.1186/s13063-026-09972-1.
PubMed 42687184
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT06367205
- Acronym / sponsor ID
- LY2023-135-A
- Keywords
- Norepinephrine, Goal-directed fluid therapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Apr 2024 (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.
Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.
Detailed description
Chronic kidney disease (CKD) presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end stage renal disease (ESRD), markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function (DGF) represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of DGF can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of DGF. Recent strides in goal-directed fluid therapy (GDFT) have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of GDFT specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of DGF in this patient demographic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-Directed Fluid Therapy (GDFT) group | Experimental | Drug: Goal-Directed Fluid Therapy (GDFT)Following anesthesia induction, patients will be connected to the FlowTrac/Vigileo monitoring system to facilitate the recording of pertinent hemodynamic parameters, including stroke volume variation (SVV), stroke volume, and cardiac output. Then, Norepinephrine Infusion Combined with Goal-directed Fluid Therapy will be administered. Efforts are made to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg. |
| Regular Fluid Therapy group | Active comparator | Drug: Regular Fluid TherapyPatients will not undergo monitoring with the FlowTrac/Vigileo system throughout the whole procedure. Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg until the conclusion of the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients aged 18 years or older
- Scheduled to undergo kidney transplantations under general anesthesia
- Cadaveric kidney transplantations
- Sign the informed consent form
Key exclusion criteria (13 listed)
- Donors aged under 18 years
- Donor kidneys classified as Maastricht category I or II
- Contraindications to radial artery catheterization
- Pregnancy
- Cardiac dysfunction (exercise tolerance less than 4 METS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Directed Fluid Therapy (GDFT)Also: GDFTNorepinephrine will be administered intravenously at a rate of 0.06 µg/kg/min, followed by the implementation of fluid therapy guided by SVV until reaching our target. In instances where SVV ≤ 13%, indicative of adequate effective circulating blood volume, the fluid infusion rate will be adjusted to 1 ml/kg/h. Conversely, if SVV > 13%, denoting inadequate effective circulating blood volume, a rapid infusion of 1 ml/kg of crystalloid fluid will be administered over 2 minutes, with subsequent observation of fluid reactivity after a further 2-minute interval. This process is reiterated until SVV ≤ 13% is attained. Should SVV > 13% recurs during surgery, the aforementioned intervention is repeated. | Drug | Goal-Directed Fluid Therapy (GDFT) group |
| Regular Fluid TherapyAnesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary | Drug | Regular Fluid Therapy group |
Primary outcome
The incidence of delayed graft function (DGF)
Time frame: Patients will be followed from postoperative day 1 to 7.
The need for dialytic intervention within the initial week post-transplantation
7 secondary outcomes
The area under the curve of serum creatinine levels from postoperative day 1 to 7
Time frame: Patients will be followed from postoperative day 1 to 7.
Duration of DGF
Time frame: Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.
Number of dialysis sessions during postoperative hospitalization
Time frame: Patients will be followed from surgery completion to discharge，an average of 20 days.
Total urine output on the second postoperative day
Time frame: Patients will be followed on the second postoperative day.
Duration of intensive care unit (ICU) stay
Time frame: Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.
Length of hospitalization
Time frame: Patients will be followed from hospitalization to discharge, an average of 20 days.
Incidence of readmission within 30 days post-discharge
Time frame: Patients will be followed from discharge to 30 days after discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 42687184Shi M, Zhang Y, Ding X, Cheng X, Zhou J, Su D. The effects of norepinephrine infusion combined with goal-directed fluid therapy on delayed graft function in patients undergoing kidney transplantations: study protocol for a multicenter randomized controlled trial. Trials. 2026 Aug 29;27(1):559. doi: 10.1186/s13063-026-09972-1.
Related trials for Delayed Graft Function
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ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
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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.
Diansan Su, Dr. principal investigator
Department of Anesthesiology Renji Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Fluid Therapy (GDFT) and Regular Fluid Therapy in people with Delayed Graft Function and End Stage Renal Disease, run by RenJi Hospital at 3 sites in China.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of delayed graft function (DGF) (time frame: Patients will be followed from postoperative day 1 to 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367205, which also lists 1 linked publication.
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 16 Apr 2024.