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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03949036
Other study ID # 1811-028-983
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date November 25, 2020

Study information

Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 25, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Other:
Crystalloid 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%
Crystalloid 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%

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum neutrophil-gelatinase-associated lipocalin (NGAL) urine biomarker of renal injury at the end of surgery
Secondary serum neutrophil-gelatinase-associated lipocalin (NGAL) urine biomarker of renal injury at the anesthesia induction procedure
Secondary Delayed graft function determined by the incidence of hemodialysis Delayed graft function determined by the incidence of hemodialysis during the first postoperative week
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Immediate graft function serum creatinine decrease less than 70% of preoperative value after eight days after surgery
Secondary slow graft function serum creatinine decrease greater than 70% of preoperative value after eight days after surgery
Secondary serum creatinine value serum creatinine value first postoperative day
Secondary serum creatinine value serum creatinine value third postoperative day
Secondary serum creatinine value serum creatinine value seventh postoperative day
Secondary Incidence of pneumonia Incidence of pneumonia during the first postoperative week
Secondary Incidence of wound infection Incidence of wound infection during the first postoperative week
Secondary Incidence of postoperative bleeding Incidence of postoperative bleeding during the first postoperative week
Secondary hospital length of stay hospital length of stay the first postoperative month
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