Clinical trial NCT04346290: Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors
Official title: Effects of Dexmedetomidine on Microcirculation and Residual Kidney Function in Kidney Donors and Transplanted Kidney Function in Kidney Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant
Microcirculation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of perfused vessel density
timeFrame: Postoperative 1 hour
Secondary outcomes:
measure: Change of creatinine level
timeFrame: Postoperative 1 day
measure: Change of perfused vessel density
timeFrame: Postoperative 1 day
measure: Change of creatinine level
timeFrame: Postoperative 1 month
measure: Change of creatinine level
timeFrame: Postoperative 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: