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

NCT04346290 | Unknown Phase 4

• 1 other identifier: 201912073MINB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Microcirculation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of creatinine level

  Postoperative 1 day

• Change of perfused vessel density

  Postoperative 1 day

• Change of creatinine level

  Postoperative 1 month

• Change of creatinine level

  Postoperative 6 months

Study Arms (2)

Control

NO INTERVENTION

Standard anesthesia care for kidney donor

Dexmedetomidine

EXPERIMENTAL

Standard anesthesia care and perioperative infusion of dexmedetomidine for kidney donor

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Initial infusion dose of dexmedetomidine is 0.4 mcg/kg/min, maintenance infusion dose is 0.1-0.7 mcg/kg/min

Dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney Donor for living kidney transplant

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yu-Chang Yeh, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chang Yeh, MD, PhD

CONTACT

+886-910513711; tonyyeh@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: April 15, 2020
• Study Start: July 24, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Starting 6 months after publication for two years
• Access Criteria: Principal investigator will review requests. The criteria for reviewing requests includes research purpose and methods of data protection.

Locations

TW (1)