Kidney TransplantPhase 4NCT04346290
Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors
A Phase 4 study testing Dexmedetomidine in people with Kidney Transplant and Microcirculation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Kidney Transplant, Microcirculation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jul 2020to Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney Donor for living kidney transplant
Who cannot join
- Allergy to dexmedetomidine
- Severe bradycardia < 50 beats per minute before surgery
- Severe atrioventricular block (the second or third degree)
- Non-native speaker
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Chang Yeh, MD, PhD, +886-9-10513711, tonyyeh@ntuh.gov.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplant, Microcirculation
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Initial infusion dose of dexmedetomidine is 0.4 mcg/kg/min, maintenance infusion dose is 0.1-0.7 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard anesthesia care for kidney donor |
| Dexmedetomidine | Experimental | Standard anesthesia care and perioperative infusion of dexmedetomidine for kidney donor Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of perfused vessel density
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.
Measured: Postoperative 1 hour
Secondary outcomes (4)
Change of creatinine level
change of creatinine level between preoperative and postoperative level
Measured: Postoperative 1 day
Change of perfused vessel density
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.
Measured: Postoperative 1 day
Change of creatinine level
change of creatinine level between preoperative and postoperative level
Measured: Postoperative 1 month
Change of creatinine level
change of creatinine level between preoperative and postoperative level
Measured: Postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start24 Jul 2020
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346290
- Sponsor's protocol ID
- 201912073MINB
- Status last verified
- Aug 2022
- First submitted
- 2 Mar 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication could be requested.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors and Transplanted Kidney Function in Kidney Recipients
- ClinicalTrials.gov ID
- NCT04346290
- Acronym / sponsor ID
- 201912073MINB
- Conditions
- Kidney Transplant, Microcirculation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard anesthesia care for kidney donor |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineStandard anesthesia care and perioperative infusion of dexmedetomidine for kidney donor |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney Donor for living kidney transplant
Key exclusion criteria (4 listed)
- Allergy to dexmedetomidine
- Severe bradycardia < 50 beats per minute before surgery
- Severe atrioventricular block (the second or third degree)
- Non-native speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineInitial infusion dose of dexmedetomidine is 0.4 mcg/kg/min, maintenance infusion dose is 0.1-0.7 mcg/kg/min | Drug | Dexmedetomidine |
Primary outcome
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.
4 secondary outcomes
Change of creatinine level
Time frame: Postoperative 1 day
Change of perfused vessel density
Time frame: Postoperative 1 day
Change of creatinine level
Time frame: Postoperative 1 month
Change of creatinine level
Time frame: Postoperative 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication could be requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Kidney Transplant and Microcirculation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chang Yeh, MD, PhD (+886-910513711, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of perfused vessel density (time frame: Postoperative 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.