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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03949036
Enrollment
60
Registered
2019-05-14
Start date
2019-05-01
Completion date
2020-11-25
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant; Complications, Renal Failure Chronic

Keywords

kidney transplantation, preload index, stroke volume variation, goad-directed therapy

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.

Interventions

OTHERCrystalloid fluid administration with the target of stroke volume variation ≤ 12%

The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%

OTHERCrystalloid fluid administration with the target of stroke volume variation ≤ 6%

The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patients do not know which group they will be enrolled. The outcome assessor will be blind to the group assignment of the participants.

Intervention model description

A randomized controlled trial of two parallel groups.

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
serum neutrophil-gelatinase-associated lipocalin (NGAL)at the end of surgeryurine biomarker of renal injury

Secondary

MeasureTime frameDescription
Delayed graft function determined by the incidence of hemodialysisduring the first postoperative weekDelayed graft function determined by the incidence of hemodialysis
Delayed graft function determined by urine output (less than 1200 ml)during the first postoperative dayDelayed graft function determined by urine output (less than 1200 ml)
Delayed graft function determined by serum creatinineduring the 48 hours after surgeryDelayed graft function determined by serum creatinine (No decrease in creatinine of more than 10% of preoperative value)
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)during the 10 days after surgeryDelayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Delayed graft function determined by glomerular filtration rateduring the 24 hours after surgeryDelayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2)
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)during the first postoperative weekDelayed graft function determined by serum creatinine (do not decrease less than preoperative value)
serum neutrophil-gelatinase-associated lipocalin (NGAL)at the anesthesia induction procedureurine biomarker of renal injury
slow graft functionafter eight days after surgeryserum creatinine decrease greater than 70% of preoperative value
serum creatinine valuefirst postoperative dayserum creatinine value
Incidence of pneumoniaduring the first postoperative weekIncidence of pneumonia
Incidence of wound infectionduring the first postoperative weekIncidence of wound infection
Incidence of postoperative bleedingduring the first postoperative weekIncidence of postoperative bleeding
hospital length of staythe first postoperative monthhospital length of stay
Immediate graft functionafter eight days after surgeryserum creatinine decrease less than 70% of preoperative value

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026