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Clinical Trial Details

Trial ID: L1502
Source ID: NCT06367205
Associated Drug: Goal-Directed Fluid Therapy (Gdft)
Title: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Delayed Graft Function|End Stage Renal Disease|Kidney Transplantation
Interventions: DRUG: Goal-Directed Fluid Therapy (GDFT)|DRUG: Regular Fluid Therapy
Outcome Measures: Primary: The incidence of delayed graft function (DGF), The need for dialytic intervention within the initial week post-transplantation, Patients will be followed from postoperative day 1 to 7. | Secondary: 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, 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, Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.|Number of dialysis sessions during postoperative hospitalization, Number of dialysis sessions during postoperative hospitalization, Patients will be followed from surgery completion to discharge,an average of 20 days.|Total urine output on the second postoperative day, Total urine output on the second postoperative day, Patients will be followed on the second postoperative day.|Duration of intensive care unit (ICU) stay, Duration of intensive care unit (ICU) stay, Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.|Length of hospitalization, Length of hospitalization, Patients will be followed from hospitalization to discharge, an average of 20 days.|Incidence of readmission within 30 days post-discharge, Incidence of readmission within 30 days post-discharge, Patients will be followed from discharge to 30 days after discharge. | Other: The incidence of acute rejection during hospitalization, The incidence of acute rejection during hospitalization, Patients will be followed from surgery completion to discharge, an average of 20 days.|The survival rates of transplanted kidneys at the one-year postoperative mark, The survival rates of transplanted kidneys at the one-year postoperative mark, Patients will be followed from surgery completion to one year after surgery.|The survival rates of transplanted patients at the one-year postoperative mark, The survival rates of transplanted patients at the one-year postoperative mark, Patients will be followed from surgery completion to one year after surgery.|The occurrence of adverse events (AEs), The occurrence of adverse events (AEs) recorded by the common terminology criteria for adverse events (CTCAE) 5.0, Patients will be followed from surgery completion to discharge, an average of 20 days.
Sponsor/Collaborators: Sponsor: RenJi Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 380
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-03-01
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2024-04-16
Locations: the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, 450052, China|General Hospital of Northern Theatre Command, Shenyang, Liaoning, 110016, China|Renji Hospital, Shanghai, Shanghai, 200127, China
URL: https://clinicaltrials.gov/show/NCT06367205