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

October 20, 2021 updated by: Won Ho Kim, MD, Seoul National University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Time Frame: at the end of surgery
urine biomarker of renal injury
at the end of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
serum neutrophil-gelatinase-associated lipocalin (NGAL)
Time Frame: at the anesthesia induction procedure
urine biomarker of renal injury
at the anesthesia induction procedure
Delayed graft function determined by the incidence of hemodialysis
Time Frame: during the first postoperative week
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)
Time Frame: during the first postoperative day
Delayed graft function determined by urine output (less than 1200 ml)
during the first postoperative day
Delayed graft function determined by serum creatinine
Time Frame: during the 48 hours after surgery
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)
Time Frame: during the 10 days after surgery
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
Time Frame: during the 24 hours after surgery
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)
Time Frame: during the first postoperative week
Delayed graft function determined by serum creatinine (do not decrease less than preoperative value)
during the first postoperative week
Immediate graft function
Time Frame: after eight days after surgery
serum creatinine decrease less than 70% of preoperative value
after eight days after surgery
slow graft function
Time Frame: after eight days after surgery
serum creatinine decrease greater than 70% of preoperative value
after eight days after surgery
serum creatinine value
Time Frame: first postoperative day
serum creatinine value
first postoperative day
serum creatinine value
Time Frame: third postoperative day
serum creatinine value
third postoperative day
serum creatinine value
Time Frame: seventh postoperative day
serum creatinine value
seventh postoperative day
Incidence of pneumonia
Time Frame: during the first postoperative week
Incidence of pneumonia
during the first postoperative week
Incidence of wound infection
Time Frame: during the first postoperative week
Incidence of wound infection
during the first postoperative week
Incidence of postoperative bleeding
Time Frame: during the first postoperative week
Incidence of postoperative bleeding
during the first postoperative week
hospital length of stay
Time Frame: the first postoperative month
hospital length of stay
the first postoperative month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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