Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Recipients aged 18 years or older
Scheduled to undergo kidney transplantations under general anesthesia
Cadaveric kidney transplantations
Sign the informed consent form
Disqualifiers
Donors aged under 18 years
Donor kidneys classified as Maastricht category I or II
Contraindications to radial artery catheterization
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Goal-Directed Fluid Therapy (GDFT)
DrugNorepinephrine 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
DrugAnesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary
Treatment groups
380 Participants
are divided into 2 treatment groupsGroup A: Goal-Directed Fluid Therapy (GDFT) groupExperimental treatment 1 intervention
Group B: Regular Fluid Therapy groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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
Time frame
Patients will be followed from postoperative day 1 to 7.2
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.3
Number of dialysis sessions during postoperative hospitalization
Number of dialysis sessions during postoperative hospitalization
Time frame
Patients will be followed from surgery completion to discharge，an average of 20 days.4
Total urine output on the second postoperative day
Total urine output on the second postoperative day
Time frame
Patients will be followed on the second postoperative day.Other outcomes
1
The incidence of acute rejection during hospitalization
The incidence of acute rejection during hospitalization
Time frame
Patients will be followed from surgery completion to discharge, an average of 20 days.2
The survival rates of transplanted kidneys at the one-year postoperative mark
The survival rates of transplanted kidneys at the one-year postoperative mark
Time frame
Patients will be followed from surgery completion to one year after surgery.3
The survival rates of transplanted patients at the one-year postoperative mark
The survival rates of transplanted patients at the one-year postoperative mark
Time frame
Patients will be followed from surgery completion to one year after surgery.4
The occurrence of adverse events (AEs)
The occurrence of adverse events (AEs) recorded by the common terminology criteria for adverse events (CTCAE) 5.0
Time frame
Patients will be followed from surgery completion to discharge, an average of 20 days.Sponsors and contacts
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Source ClinicalTrials.gov