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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06367205
Other study ID # LY2023-135-A
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date June 30, 2026

Study information

Verified date April 2024
Source RenJi Hospital
Contact Diansan Su, Dr.
Phone +862168383702
Email diansansu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 380
Est. completion date June 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Recipients aged 18 years or older 2. Scheduled to undergo kidney transplantations under general anesthesia 3. Cadaveric kidney transplantations 4. Sign the informed consent form Exclusion Criteria: 1. Donors aged under 18 years 2. Donor kidneys classified as Maastricht category I or II 3. Contraindications to radial artery catheterization 4. Pregnancy 5. Cardiac dysfunction (exercise tolerance less than 4 METS) 6. Severe liver dysfunction (Child Pugh C-grade) 7. Respiratory diseases with tidal volume intolerance exceeding 8ml/kg 8. Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation 9. Double-kidney transplantations 10. Simultaneous organ or additional surgeries during kidney transplantations 11. Repeat kidney transplantations 12. Concurrent participation in other clinical trials 13. Patients deemed ineligible by researchers

Study Design


Intervention

Drug:
Goal-Directed Fluid Therapy (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 Therapy
Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary

Locations

Country Name City State
China Renji Hospital Shanghai Shanghai
China General Hospital of Northern Theatre Command Shenyang Liaoning
China the First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The incidence of acute rejection during hospitalization The incidence of acute rejection during hospitalization Patients will be followed from surgery completion to discharge, an average of 20 days.
Other The survival rates of transplanted kidneys at the one-year postoperative mark The survival rates of transplanted kidneys at the one-year postoperative mark Patients will be followed from surgery completion to one year after surgery.
Other The survival rates of transplanted patients at the one-year postoperative mark The survival rates of transplanted patients at the one-year postoperative mark Patients will be followed from surgery completion to one year after surgery.
Other The occurrence of adverse events (AEs) The occurrence of adverse events (AEs) recorded by the common terminology criteria for adverse events (CTCAE) 5.0 Patients will be followed from surgery completion to discharge, an average of 20 days.
Primary The incidence of delayed graft function (DGF) The need for dialytic intervention within the initial week post-transplantation Patients will be followed from postoperative day 1 to 7.
Secondary 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 Patients will be followed from postoperative day 1 to 7.
Secondary Duration of DGF The interval from surgery completion to the last dialysis up to 84 days post-surgery Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.
Secondary Number of dialysis sessions during postoperative hospitalization Number of dialysis sessions during postoperative hospitalization Patients will be followed from surgery completion to discharge,an average of 20 days.
Secondary Total urine output on the second postoperative day Total urine output on the second postoperative day Patients will be followed on the second postoperative day.
Secondary Duration of intensive care unit (ICU) stay Duration of intensive care unit (ICU) stay Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.
Secondary Length of hospitalization Length of hospitalization Patients will be followed from hospitalization to discharge, an average of 20 days.
Secondary Incidence of readmission within 30 days post-discharge Incidence of readmission within 30 days post-discharge Patients will be followed from discharge to 30 days after discharge.
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