Actively Recruiting
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial
Led by RenJi Hospital · Updated on 2024-04-16
380
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether norepinephrine infusion combined with goal-directed fluid therapy (GDFT) can reduce the occurrence of delayed graft function (DGF) in patients undergoing kidney transplantation. DGF, defined as the need for dialysis within the first week after transplant, affects 20% to 50% of recipients and can lead to serious complications including graft failure and rejection. Kidney transplantation is a key treatment for end-stage renal disease, but managing fluid during surgery is critical to improving outcomes, and the role of GDFT in this context is still uncertain. Participants will be randomly assigned to one of two groups. The experimental group will receive norepinephrine infusion at 0.06 µg/kg/min combined with fluid therapy guided by stroke volume variation (SVV) to maintain adequate blood volume and a mean arterial pressure (MAP) of 80 mmHg or higher during surgery. The control group will receive regular fluid therapy managed by anesthesiologists using clinical judgment to maintain MAP at or above 80 mmHg without the specialized monitoring system. Both approaches aim to optimize blood pressure and fluid status throughout the transplant procedure. Throughout the study, participants will be monitored closely from the day of surgery through up to 84 days post-operation. Researchers will track the incidence and duration of delayed graft function, serum creatinine levels, number of dialysis sessions, urine output, length of ICU stay, total hospitalization time, and readmission rates within 30 days after discharge. These measures will help assess the impact of the fluid management strategies on transplant outcomes and patient recovery over the initial critical period following kidney transplantation.
CONDITIONS
Brief Title
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recipients aged 18 years or older
- Scheduled to undergo kidney transplantations under general anesthesia
- Cadaveric kidney transplantations
- Signed informed consent form
You will not qualify if you...
- Donors aged under 18 years
- Donor kidneys classified as Maastricht category I or II
- Contraindications to radial artery catheterization
- Pregnancy
- Cardiac dysfunction with 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo kidney transplantation surgery with specific fluid therapy management during the procedure.
1 visit (in-person)
Duration - Up to 84 days after surgery
Participants are monitored for delayed graft function and recovery following kidney transplantation.
Daily visits or assessments from postoperative day 1 to 7, then ongoing monitoring until discharge and up to 30 days post-discharge
Trial Site Locations
Total: 3 locations
1
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
2
General Hospital of Northern Theatre Command
Shenyang, Liaoning, China, 110016
Not Yet Recruiting
3
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
D
Diansan Su, Dr.
M
Muyan Shi, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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