Clinical trial NCT06367205: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delayed Graft Function
End Stage Renal Disease
Kidney Transplantation
Keywords: Norepinephrine
Goal-directed fluid therapy
Randomized controlled trial
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of delayed graft function (DGF)
timeFrame: Patients will be followed from postoperative day 1 to 7.
Secondary outcomes:
measure: The area under the curve of serum creatinine levels from postoperative day 1 to 7
timeFrame: Patients will be followed from postoperative day 1 to 7.
measure: Duration of DGF
timeFrame: Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.
measure: Number of dialysis sessions during postoperative hospitalization
timeFrame: Patients will be followed from surgery completion to discharge，an average of 20 days.
measure: Total urine output on the second postoperative day
timeFrame: Patients will be followed on the second postoperative day.
measure: Duration of intensive care unit (ICU) stay
timeFrame: Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.
measure: Length of hospitalization
timeFrame: Patients will be followed from hospitalization to discharge, an average of 20 days.
measure: Incidence of readmission within 30 days post-discharge
timeFrame: Patients will be followed from discharge to 30 days after discharge.
Other outcomes:
measure: The incidence of acute rejection during hospitalization
timeFrame: Patients will be followed from surgery completion to discharge, an average of 20 days.
measure: The survival rates of transplanted kidneys at the one-year postoperative mark
timeFrame: Patients will be followed from surgery completion to one year after surgery.
measure: The survival rates of transplanted patients at the one-year postoperative mark
timeFrame: Patients will be followed from surgery completion to one year after surgery.
measure: The occurrence of adverse events (AEs)
timeFrame: Patients will be followed from surgery completion to discharge, an average of 20 days.
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Zhengzhou University
state: Henan
city: Shenyang
country: China
facility: General Hospital of Northern Theatre Command
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Anesthesiology Renji Hospital
name: Diansan Su, Dr.
role: PRINCIPAL_INVESTIGATOR
References: