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

NCT ID: NCT03949036

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-11-25

Brief Summary

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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

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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.

Conditions

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Kidney Transplant; Complications Renal Failure Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial of two parallel groups.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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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%

Intervention Type 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%

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1811-028-983

Identifier Type: -

Identifier Source: org_study_id