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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure Chronic; Kidney Transplant; Complications
• Intervention / Treatment: Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 6%; Other: Crystalloid fluid administration with the target of stroke volume variation ≤ 12%

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: target of Stroke Volume Variation ≤ 6%; 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%; The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%
Active Comparator: target of Stroke Volume Variation ≤ 12%; 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%; The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): November 25, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: kidney transplantation; stroke volume variation; preload index; goad-directed therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1811-028-983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No