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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Kidney Transplantation; End Stage Renal Disease; Delayed Graft Function

Treatments: Drug: Goal-Directed Fluid Therapy (GDFT); Drug: Regular Fluid Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06367205

LY2023-135-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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380 participants in 2 patient groups

Goal-Directed Fluid Therapy (GDFT) group

Experimental group

Description:

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.

Treatment:

Drug: Goal-Directed Fluid Therapy (GDFT)

Regular Fluid Therapy group

Active Comparator group

Description:

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.

Treatment:

Drug: Regular Fluid Therapy