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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-Directed Fluid Therapy (GDFT) group | Experimental | 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 ā„ 80 mmHg. |
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| Regular Fluid Therapy group | Active Comparator | 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 ā„ 80 mmHg until the conclusion of the surgical procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal-Directed Fluid Therapy (GDFT) | Drug | Norepinephrine will be administered intravenously at a rate of 0.06 Āµg/kg/min, followed by the implementation of fluid therapy guided by SVV until reaching our target. In instances where SVV ā¤ 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 ā¤ 13% is attained. Should SVV > 13% recurs during surgery, the aforementioned intervention is repeated. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diansan Su, Dr. | Contact | +862168383702 | diansansu@yahoo.com | |
| Muyan Shi, B.S. | Contact | +862168383702 | jsqdsmy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Diansan Su, Dr. | Department of Anesthesiology Renji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Regular Fluid Therapy | Drug | Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary |
|
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 dischargeļ¼an 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. |
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. |
| General Hospital of Northern Theatre Command | Not yet recruiting | Shenyang | Liaoning | 110016 | China |
|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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