Clinical trial NCT03949036: Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation
Official title: Comparison of Two Different Preload Targets of Stroke Volume Variation During Kidney Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Renal Failure Chronic
Keywords: kidney transplantation
preload index
stroke volume variation
goad-directed therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial of two parallel groups.
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: serum neutrophil-gelatinase-associated lipocalin (NGAL)
timeFrame: at the end of surgery
Secondary outcomes:
measure: serum neutrophil-gelatinase-associated lipocalin (NGAL)
timeFrame: at the anesthesia induction procedure
measure: Delayed graft function determined by the incidence of hemodialysis
timeFrame: during the first postoperative week
measure: Delayed graft function determined by urine output (less than 1200 ml)
timeFrame: during the first postoperative day
measure: Delayed graft function determined by serum creatinine
timeFrame: during the 48 hours after surgery
measure: Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
timeFrame: during the 10 days after surgery
measure: Delayed graft function determined by glomerular filtration rate
timeFrame: during the 24 hours after surgery
measure: Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
timeFrame: during the first postoperative week
measure: Immediate graft function
timeFrame: after eight days after surgery
measure: slow graft function
timeFrame: after eight days after surgery
measure: serum creatinine value
timeFrame: first postoperative day
measure: serum creatinine value
timeFrame: third postoperative day
measure: serum creatinine value
timeFrame: seventh postoperative day
measure: Incidence of pneumonia
timeFrame: during the first postoperative week
measure: Incidence of wound infection
timeFrame: during the first postoperative week
measure: Incidence of postoperative bleeding
timeFrame: during the first postoperative week
measure: hospital length of stay
timeFrame: the first postoperative month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: