Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation

Study Overview
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Brief Summary
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The investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.

Detailed Description
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The adequate preload target of fluid management has not yet been established during kidney transplantation. Traditionally, sufficient intravascular volume status has been recommended to maintain perfusion to renal graft. Stroke volume variation was reported to be superior to the traditional target of central venous pressure. In this regard, the investigators sought to compare the effect of two preload targets of stroke volume variation of ≤6% and ≤12% on the postoperative renal function in patients undergoing living donor kidney transplantation. Goal-directed fluid therapy will be performed in both groups to maintain adequate stroke volume, stroke volume variation, mean arterial pressure (or systemic vascular resistance) during kidney transplantation. Only the preload target for giving crystalloid during surgery will be different between groups.

Official Title
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Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial

Conditions
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Kidney Transplant; Complications, Renal Failure Chronic

Intervention / Treatment
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* Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12%
* Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 6%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults patients who are undergoing living donor kidney transplantation with continuous radial artery pressure monitoring Exclusion Criteria: Patients who have cardiac arrhythmia of atrial fibrillation, multiple ventricular premature complex Cardiac systolic dysfunction with left ventricle ejection fraction <50% Continuous arterial pressure monitoring at the site other than radial artery. Patients who are considered to be intolerant to rapid fluid administration

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial of two parallel groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: target of Stroke Volume Variation ≤ 6%<br>The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 6%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. | Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 6%<br>* The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%<br>|
| Active Comparator: target of Stroke Volume Variation ≤ 12%<br>The rate of intraoperative fluid administration will be adjusted to achieve the target of Stroke Volume Variation ≤ 12%. A crystalloid bolus of 200 ml will be repeatedly administered every 20 min until the target was achieved. The basal rate of fluid administration will be 3 ml/kg/hr. | Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12%<br>* The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum neutrophil-gelatinase-associated lipocalin (NGAL) | urine biomarker of renal injury | at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum neutrophil-gelatinase-associated lipocalin (NGAL) | urine biomarker of renal injury | at the anesthesia induction procedure | 
| Delayed graft function determined by the incidence of hemodialysis | Delayed graft function determined by the incidence of hemodialysis | during the first postoperative week | 
| Delayed graft function determined by urine output (less than 1200 ml) | Delayed graft function determined by urine output (less than 1200 ml) | during the first postoperative day | 
| Delayed graft function determined by serum creatinine | Delayed graft function determined by serum creatinine (No decrease in creatinine of more than 10% of preoperative value) | during the 48 hours after surgery | 
| Delayed graft function determined by serum creatinine (more than 2.5 mg/dL) | Delayed graft function determined by serum creatinine (more than 2.5 mg/dL) | during the 10 days after surgery | 
| Delayed graft function determined by glomerular filtration rate | Delayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2) | during the 24 hours after surgery | 
| Delayed graft function determined by serum creatinine (do not decrease less than preoperative value) | Delayed graft function determined by serum creatinine (do not decrease less than preoperative value) | during the first postoperative week | 
| Immediate graft function | serum creatinine decrease less than 70% of preoperative value | after eight days after surgery | 
| slow graft function | serum creatinine decrease greater than 70% of preoperative value | after eight days after surgery | 
| serum creatinine value | serum creatinine value | first postoperative day | 
| serum creatinine value | serum creatinine value | third postoperative day | 
| serum creatinine value | serum creatinine value | seventh postoperative day | 
| Incidence of pneumonia | Incidence of pneumonia | during the first postoperative week | 
| Incidence of wound infection | Incidence of wound infection | during the first postoperative week | 
| Incidence of postoperative bleeding | Incidence of postoperative bleeding | during the first postoperative week | 
| hospital length of stay | hospital length of stay | the first postoperative month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, preload index, stroke volume variation, goad-directed therapy