Kidney TransplantationNCT03327389
Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation
A study testing Dexmedetomidine in people with Kidney Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2017to 28 Sep 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (20-80 years old)
- patients undergoing elective kidney transplantation
Who cannot join
- emergency surgery
- severe sinus bradycardia (<50 beats per min [bpm])
- second-degree or third-degree heart block
- decreased heart function (EF <30%)
- acute myocardial ischemia
- serious hepatic dysfunction (Child-Pugh class C)
- patients with known or suspected severe adverse reactions to DEX (or clonidine)
- treatment with clonidine or dexmedetomidine in the past 30 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, 03722
Jin Ha Park, MD, 82-2-2228-2420 ext. 82-2-2227-7897, realsummer@yuhs.ac
About this study
The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation
- Conditions
- Kidney Transplantation
- Being tested
- Dexmedetomidine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.
placeboDrug
0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine (Group D) | Experimental | Dexmedetomidine infusion during surgery Dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure Receives: Drug: Dexmedetomidine |
| Control (Group C) | Placebo comparator | 0.9% NaCl infusion during surgery 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine level
Measured: postoperative 7 day
Secondary outcomes (9)
incidence of delayed graft function
Measured: 7 days after surgery
level of serum creatinine
Measured: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
blood urea nitrogen (BUN)
Measured: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
cystatin C
Measured: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
Neutrophil gelatinase-associated lipocalin (NGAL)
Measured: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
urine output
Measured: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))
Measured: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
kidney ultrasound
Measured: 1 week, 1 month after surgery, if possible
inflammatory mediator (IL-18, Il-1b) level
Measured: immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2017
- Primary completion28 Sep 2019 (estimated)
- Study completion28 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Dexmedetomidine group 2. Control group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327389
- Sponsor's protocol ID
- 4-2017-0767
- Status last verified
- Jan 2019
- First submitted
- 23 Oct 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JH, Koo BN, Kim MS, Shin D, Kwak YL. Effects of intraoperative dexmedetomidine infusion on renal function in elective living donor kidney transplantation: a randomized controlled trial. Can J Anaesth. 2022 Apr;69(4):448-459. doi: 10.1007/s12630-021-02173-1. Epub 2021 Dec 20.
PubMed 34931289
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Renal Function and Delayed Graft Function After Kidney Transplantation
- ClinicalTrials.gov ID
- NCT03327389
- Acronym / sponsor ID
- 4-2017-0767
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 Sep 2019 (estimated)
- Study completion
- 28 Sep 2019 (estimated)
- First posted
- 31 Oct 2017 (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.
The purpose of this study is to elucidate the effect of dexmedetomidine on renal function and delayed graft function after kidney transplantation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Dexmedetomidine group 2. Control group
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine (Group D) | Experimental | Drug: DexmedetomidineDexmedetomidine infusion during surgery Dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure |
| Control (Group C) | Placebo comparator | Drug: placebo0.9% NaCl infusion during surgery 0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult (20-80 years old)
- patients undergoing elective kidney transplantation
Key exclusion criteria (8 listed)
- emergency surgery
- severe sinus bradycardia (<50 beats per min [bpm])
- second-degree or third-degree heart block
- decreased heart function (EF <30%)
- acute myocardial ischemia
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 |
|---|---|---|
| Dexmedetomidinedexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure. | Drug | Dexmedetomidine (Group D) |
| placebo0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure | Drug | Control (Group C) |
Primary outcome
Serum creatinine level
Time frame: postoperative 7 day
9 secondary outcomes
incidence of delayed graft function
Time frame: 7 days after surgery
level of serum creatinine
Time frame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
blood urea nitrogen (BUN)
Time frame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
cystatin C
Time frame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: maximum 30 days before surgery, 1 hour after surgery, 1 day, 2 day, 3 day, 5 day, 7 day after surgery
urine output
Time frame: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
fluid intake(intraoperative intake and output measured by the amount of fluid(crystalloid/colloid)(mL) and blood administered(mL))
Time frame: during surgery, 1 day, 2 day, 3 day, 4 day, 5 day, 6 day, 7 day after surgery
kidney ultrasound
Time frame: 1 week, 1 month after surgery, if possible
inflammatory mediator (IL-18, Il-1b) level
Time frame: immediately after induction, immediately after vessel clamp, immediately after reperfusion, 1hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 34931289Park JH, Koo BN, Kim MS, Shin D, Kwak YL. Effects of intraoperative dexmedetomidine infusion on renal function in elective living donor kidney transplantation: a randomized controlled trial. Can J Anaesth. 2022 Apr;69(4):448-459. doi: 10.1007/s12630-021-02173-1. Epub 2021 Dec 20.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Kidney Transplantation, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 8 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 15 Jan 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jin Ha Park, MD (82-2-2228-2420 ext. 82-2-2227-7897, realsummer@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine level (time frame: postoperative 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03327389, which also lists 1 linked publication.
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 15 Jan 2019.