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

RenJi Hospital380 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Goal-Directed Fluid Therapy (GDFT)DRUG

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 TherapyDRUG

Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT_YET_RECRUITING

General Hospital of Northern Theatre Command

Shenyang, Liaoning, China

NOT_YET_RECRUITING

Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The incidence of delayed graft function (DGF)

The need for dialytic intervention within the initial week post-transplantation

Time frame: Patients will be followed from postoperative day 1 to 7.

Secondary Outcomes

The area under the curve of serum creatinine levels from postoperative day 1 to 7

Time frame: Patients will be followed from postoperative day 1 to 7.

Duration of DGF

The interval from surgery completion to the last dialysis up to 84 days post-surgery

Time frame: Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.

Number of dialysis sessions during postoperative hospitalization

Time frame: Patients will be followed from surgery completion to discharge，an average of 20 days.

Total urine output on the second postoperative day

Time frame: Patients will be followed on the second postoperative day.

Duration of intensive care unit (ICU) stay

Time frame: Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.

Length of hospitalization

Time frame: Patients will be followed from hospitalization to discharge, an average of 20 days.

Incidence of readmission within 30 days post-discharge

Time frame: Patients will be followed from discharge to 30 days after discharge.