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

Primary Purpose

Kidney Transplant; Complications, Renal Failure Chronic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Crystalloid fluid administration with the target of stroke volume variation ≤ 12%
Crystalloid fluid administration with the target of stroke volume variation ≤ 6%
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplant; Complications focused on measuring kidney transplantation, preload index, stroke volume variation, goad-directed therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

target of Stroke Volume Variation ≤ 6%

target of Stroke Volume Variation ≤ 12%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

serum neutrophil-gelatinase-associated lipocalin (NGAL)
urine biomarker of renal injury

Secondary Outcome Measures

serum neutrophil-gelatinase-associated lipocalin (NGAL)
urine biomarker of renal injury
Delayed graft function determined by the incidence of hemodialysis
Delayed graft function determined by the incidence of hemodialysis
Delayed graft function determined by urine output (less than 1200 ml)
Delayed graft function determined by urine output (less than 1200 ml)
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)
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)
Delayed graft function determined by glomerular filtration rate
Delayed 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)
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Immediate graft function
serum creatinine decrease less than 70% of preoperative value
slow graft function
serum creatinine decrease greater than 70% of preoperative value
serum creatinine value
serum creatinine value
serum creatinine value
serum creatinine value
serum creatinine value
serum creatinine value
Incidence of pneumonia
Incidence of pneumonia
Incidence of wound infection
Incidence of wound infection
Incidence of postoperative bleeding
Incidence of postoperative bleeding
hospital length of stay
hospital length of stay

Full Information

First Posted
May 11, 2019
Last Updated
October 20, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03949036
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant; Complications, Renal Failure Chronic
Keywords
kidney transplantation, preload index, stroke volume variation, goad-directed therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial of two parallel groups.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
target of Stroke Volume Variation ≤ 6%
Arm Type
Experimental
Arm Description
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.
Arm Title
target of Stroke Volume Variation ≤ 12%
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Crystalloid fluid administration with the target of stroke volume variation ≤ 12%
Intervention Description
The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 12%
Intervention Type
Other
Intervention Name(s)
Crystalloid fluid administration with the target of stroke volume variation ≤ 6%
Intervention Description
The rate of crystalloid fluid administration will be controlled to achieve the target of stroke volume variation ≤ 6%
Primary Outcome Measure Information:
Title
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Description
urine biomarker of renal injury
Time Frame
at the end of surgery
Secondary Outcome Measure Information:
Title
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Description
urine biomarker of renal injury
Time Frame
at the anesthesia induction procedure
Title
Delayed graft function determined by the incidence of hemodialysis
Description
Delayed graft function determined by the incidence of hemodialysis
Time Frame
during the first postoperative week
Title
Delayed graft function determined by urine output (less than 1200 ml)
Description
Delayed graft function determined by urine output (less than 1200 ml)
Time Frame
during the first postoperative day
Title
Delayed graft function determined by serum creatinine
Description
Delayed graft function determined by serum creatinine (No decrease in creatinine of more than 10% of preoperative value)
Time Frame
during the 48 hours after surgery
Title
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Description
Delayed graft function determined by serum creatinine (more than 2.5 mg/dL)
Time Frame
during the 10 days after surgery
Title
Delayed graft function determined by glomerular filtration rate
Description
Delayed graft function determined by glomerular filtration rate (less than 10 ml/min/m2)
Time Frame
during the 24 hours after surgery
Title
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Description
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
Time Frame
during the first postoperative week
Title
Immediate graft function
Description
serum creatinine decrease less than 70% of preoperative value
Time Frame
after eight days after surgery
Title
slow graft function
Description
serum creatinine decrease greater than 70% of preoperative value
Time Frame
after eight days after surgery
Title
serum creatinine value
Description
serum creatinine value
Time Frame
first postoperative day
Title
serum creatinine value
Description
serum creatinine value
Time Frame
third postoperative day
Title
serum creatinine value
Description
serum creatinine value
Time Frame
seventh postoperative day
Title
Incidence of pneumonia
Description
Incidence of pneumonia
Time Frame
during the first postoperative week
Title
Incidence of wound infection
Description
Incidence of wound infection
Time Frame
during the first postoperative week
Title
Incidence of postoperative bleeding
Description
Incidence of postoperative bleeding
Time Frame
during the first postoperative week
Title
hospital length of stay
Description
hospital length of stay
Time Frame
the first postoperative month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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