RecruitingNot ApplicableNCT06367205

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

Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial


Sponsor

RenJi Hospital

Enrollment

380 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Recipients aged 18 years or older
  • Scheduled to undergo kidney transplantations under general anesthesia
  • Cadaveric kidney transplantations
  • Sign the informed consent form

Exclusion Criteria13

  • Donors aged under 18 years
  • Donor kidneys classified as Maastricht category I or II
  • Contraindications to radial artery catheterization
  • Pregnancy
  • Cardiac dysfunction (exercise tolerance less than 4 METS)
  • Severe liver dysfunction (Child Pugh C-grade)
  • Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
  • Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
  • Double-kidney transplantations
  • Simultaneous organ or additional surgeries during kidney transplantations
  • Repeat kidney transplantations
  • Concurrent participation in other clinical trials
  • Patients deemed ineligible by researchers

Interventions

DRUGGoal-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.

DRUGRegular 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(3)

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

General Hospital of Northern Theatre Command

Shenyang, Liaoning, China

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT06367205


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