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

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: Recruiting
• Conditions: Kidney Transplant; Microcirculation
• Intervention / Treatment: Drug: Dexmedetomidine

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of creatinine level	change of creatinine level between preoperative and postoperative level	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.	Postoperative 1 day
Change of creatinine level	change of creatinine level between preoperative and postoperative level	Postoperative 1 month
Change of creatinine level	change of creatinine level between preoperative and postoperative level	Postoperative 6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID 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