Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors

August 15, 2022 updated by: National Taiwan University Hospital

Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors and Transplanted Kidney Function in Kidney Recipients

Kidney transplant can help patients with end-stage kidney disease to get rid of dialysis and have a good quality life. However, during the renal donation operation, the stress response and subsequent inflammatory responses may result in damage to the residual kidney and transplanted kidney. Dexmedetomidine can increase urine output and decrease the neutrophil gelatinase associated lipocalin level in patients receiving coronary artery bypass surgery. The primary goal of this trial is to investigate the effects of perioperative infusion of dexmedetomidine on the microcirculation and residual kidney function in kidney donors and on the transplanted kidney function in kidney recipients.

Study Overview

Status

Status

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

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

Kidney transplant can help patients with end-stage kidney disease to get rid of dialysis and have a good quality life. However, during the renal donation operation, the stress response and subsequent inflammatory responses may result in damage to the residual kidney and transplanted kidney. In addition, the transplanted kidney will encounter ischemic and reperfusion injuries during kidney transplant, and it may affect its function. It has been reported in several animal studies that dexmedetomidine can reduce microcirculatory dysfunction, kidney injury, and intestinal injury. Moreover, dexmedetomidine can increase urine output and decrease the neutrophil gelatinase associated lipocalin level in patients receiving coronary artery bypass surgery. The primary goal of this trial is to investigate the effects of perioperative infusion of dexmedetomidine on the microcirculation and residual kidney function in kidney donors and on the transplanted kidney function in kidney recipients. This is a single blind and randomized controlled trial. The participants will be randomly assigned to the Control group or Dexmedetomidine group. The participants in the Control group will receive standard anesthesia care for kidney donation operation. Beside the standard anesthesia care, the participants in the Dexmedetomidine group will receive continuously intravascular infusion of dexmedetomidine since 10 minutes after anesthesia till one hour after operation. At several specific time points, participants will receive sublingual microcirculation examination by using an incident dark field video microscope and blood tests. The chart information will be recorded. The blood creatinine level of the kidney donors and recipients at 1 and 6 months will be recorded.

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 (Anticipated)

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.
120

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.
  • Phase 4

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

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Kidney Donor for living kidney transplant

Exclusion Criteria:

  • Allergy to dexmedetomidine
  • Severe bradycardia < 50 beats per minute before surgery
  • Severe atrioventricular block (the second or third degree)
  • Non-native speaker

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
NO_INTERVENTION: Control
Standard anesthesia care for kidney donor
EXPERIMENTAL: Dexmedetomidine
Standard anesthesia care and perioperative infusion of dexmedetomidine for kidney donor
Drug: Dexmedetomidine
Initial infusion dose of dexmedetomidine is 0.4 mcg/kg/min, maintenance infusion dose is 0.1-0.7 mcg/kg/min

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
Change of perfused vessel density
Time Frame: Postoperative 1 hour
Sublingual microcirculation is measured by incidental dark field video microscope (CytoCam). Perfused vessel density is equal to perfused vessel length (in millimeter) divided by total vessel length (in millimeter) in a square millimeter.
Postoperative 1 hour

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
Change of creatinine level
Time Frame: Postoperative 1 day
change of creatinine level between preoperative and postoperative level
Postoperative 1 day
Change of perfused vessel density
Time Frame: Postoperative 1 day
Sublingual microcirculation is measured by incidental dark field video microscope (CytoCam). Perfused vessel density is equal to perfused vessel length (in millimeter) divided by total vessel length (in millimeter) in a square millimeter.
Postoperative 1 day
Change of creatinine level
Time Frame: Postoperative 1 month
change of creatinine level between preoperative and postoperative level
Postoperative 1 month
Change of creatinine level
Time Frame: Postoperative 6 months
change of creatinine level between preoperative and postoperative level
Postoperative 6 months

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.
National Taiwan 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.
July 24, 2020

Primary Completion (ANTICIPATED)

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.
December 1, 2023

Study Completion (ANTICIPATED)

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.
June 1, 2024

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).
March 2, 2020

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.
April 14, 2020

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.
April 15, 2020

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.
August 17, 2022

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.
August 15, 2022

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.
August 1, 2022

More Information

Terms related to this study

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.
  • 201912073MINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data that underlie results in a publication could be requested.

IPD Sharing Time Frame

Starting 6 months after publication for two years

IPD Sharing Access Criteria

Principal investigator will review requests. The criteria for reviewing requests includes research purpose and methods of data protection.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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