Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367205
• Other study ID #: LY2023-135-A
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Delayed Graft Function
• End Stage Renal Disease
• Kidney Failure, Chronic
• Kidney Transplantation

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.