A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01870011
First received: May 30, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R injury and maintaining renal function during renal transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both kidney donors and recipients during deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.


Condition Intervention Phase
End Stage Renal Disease
Drug: Desflurane balanced anesthesia
Drug: Propofol total intravenous anesthesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β) [ Time Frame: Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction ] [ Designated as safety issue: No ]
    1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
    2. Kidney recipient:

    (1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively



Secondary Outcome Measures:
  • The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL) [ Time Frame: immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction ] [ Designated as safety issue: No ]
    1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
    2. Kidney recipient:

    (1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively



Other Outcome Measures:
  • The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense) [ Time Frame: changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion ] [ Designated as safety issue: No ]
    1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
    2. Kidney recipient:

    (1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively



Estimated Enrollment: 192
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desflurane balanced anesthesia group Drug: Desflurane balanced anesthesia
Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
Active Comparator: Propofol total intravenous anesthesia group Drug: Propofol total intravenous anesthesia
Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation

Exclusion Criteria:

1. Donor exclusion criteria:

(1) Refusal of legal guardian

2. Recipient exclusion criteria:

  1. Patient refusal
  2. Hypersensitivity to propofol, soybeans or peanuts
  3. History of vitamin C or E intake within 5 days before surgery
  4. History of acute myocardial infarct within 6 months before surgery
  5. Congestive heart failure (NYHA III-IV)
  6. Autoimmune disease patients
  7. BMI over 30 kg/m2
  8. Left ventricular ejection fraction less than 35% upon preoperative echocardiography
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870011

Contacts
Contact: Young Chul Yoo, MD 82-2-2228-2420 seaoyster@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Young Chul Yoo, MD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01870011     History of Changes
Other Study ID Numbers: 4-2013-0208
Study First Received: May 30, 2013
Last Updated: July 24, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Propofol, renal protection, kidney transplantation

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Propofol
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 20, 2014