An interventional study of Goal-Directed Fluid Therapy (GDFT) and Regular Fluid Therapy in Delayed Graft Function, End Stage Renal Disease and Kidney Transplantation, sponsored by RenJi Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Prevention
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's planned enrollment of 380 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
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A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Contraindication
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Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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Following anesthesia induction, patients will be connected to the FlowTrac/Vigileo monitoring system to facilitate the recording of pertinent hemodynamic parameters, including stroke volume variation (SVV), stroke volume, and cardiac output. Then, Norepinephrine Infusion Combined with Goal-directed Fluid Therapy will be administered. Efforts are made to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg.
Drug: Goal-Directed Fluid Therapy (GDFT)
Patients will not undergo monitoring with the FlowTrac/Vigileo system throughout the whole procedure. Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg until the conclusion of the surgical procedure.
Drug: Regular Fluid Therapy
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.
Also known as: GDFT
Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary
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.
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.
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
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
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
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
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
Incidence of readmission within 30 days post-discharge
Time frame: Patients will be followed from discharge to 30 days after discharge.
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.
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.
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.
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.
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