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

Not Applicable

Recruiting

• Conditions: Delayed Graft Function; End Stage Renal Disease; Kidney Transplantation
• Interventions: Drug: Regular Fluid Therapy; Drug: Goal-Directed Fluid Therapy (GDFT)

• Registration Number: NCT06367205
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regular Fluid Therapy group	Regular Fluid Therapy	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.
Goal-Directed Fluid Therapy (GDFT) group	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.

Primary Outcome Measures

Name	Time	Method
The incidence of delayed graft function (DGF)	Patients will be followed from postoperative day 1 to 7.	The need for dialytic intervention within the initial week post-transplantation

Secondary Outcome Measures

Name	Time	Method
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.	The area under the curve of serum creatinine levels from postoperative day 1 to 7
Number of dialysis sessions during postoperative hospitalization	Patients will be followed from surgery completion to discharge，an average of 20 days.	Number of dialysis sessions during postoperative hospitalization
Duration of DGF	Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.	The interval from surgery completion to the last dialysis up to 84 days post-surgery
Total urine output on the second postoperative day	Patients will be followed on the second postoperative day.	Total urine output on the second postoperative day
Duration of intensive care unit (ICU) stay	Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.	Duration of intensive care unit (ICU) stay
Length of hospitalization	Patients will be followed from hospitalization to discharge, an average of 20 days.	Length of hospitalization
Incidence of readmission within 30 days post-discharge	Patients will be followed from discharge to 30 days after discharge.	Incidence of readmission within 30 days post-discharge

Trial Locations

Locations (3)

the First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

General Hospital of Northern Theatre Command; 🇨🇳 Shenyang, Liaoning, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China