Renal FailureNCT02874378
Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients
A study testing Dexmedetomidine and 0.9%NaCl solution in people with Renal Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Dexmedetomidine and 0.9%NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2017
- 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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.
Who cannot join
- severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 1st affiliated hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jing Xu, 014434670949, xuj0909@163.com
About this study
Official title: Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial
Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.
Read the detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.
- Conditions
- Renal Failure
- Being tested
- Dexmedetomidine, 0.9%NaCl solution
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine Injection
0.9%NaCl solutionDrug
Also called normal saline
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Dexmedetomidine will be pumped at 0.3μg/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients. Receives: Drug: Dexmedetomidine |
| control group | Placebo comparator | 0.9%NaCl solution 0.1ml/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients. Receives: Drug: 0.9%NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystatin C level
Measured: 2 weeks
Secondary outcomes (5)
average daily urinary volume
Measured: 2 weeks
length of hospital stay (LOS)
Measured: an expected average of 2 weeks
Wake up time, extubation time,SAS score,PONV
Measured: up to 6 hours
total dosage of remifentanil
Measured: up to 4 hours
Cr/GFR improvement
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874378
- Sponsor's protocol ID
- XJTU1AFCT-2016-023
- Status last verified
- Jan 2017
- First submitted
- 9 Aug 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02874378
- Acronym / sponsor ID
- XJTU1AFCT-2016-023
- Conditions
- Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Aug 2016 (estimated)
- 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.
Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.
Detailed description
Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: DexmedetomidineDexmedetomidine will be pumped at 0.3μg/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients. |
| control group | Placebo comparator | Drug: 0.9%NaCl solution0.9%NaCl solution 0.1ml/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.
Key exclusion criteria (1 listed)
- severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.
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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine Injection | Drug | study group |
| 0.9%NaCl solutionAlso: normal saline | Drug | control group |
Primary outcome
Cystatin C level
Time frame: 2 weeks
5 secondary outcomes
average daily urinary volume
Time frame: 2 weeks
length of hospital stay (LOS)
Time frame: an expected average of 2 weeks
Wake up time, extubation time,SAS score,PONV
Time frame: up to 6 hours
total dosage of remifentanil
Time frame: up to 4 hours
Cr/GFR improvement
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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 and 0.9%NaCl solution in people with Renal Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 1 inclusion and 1 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 20 Jan 2017. 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 China. 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 Jing Xu, MD (13772052823, xuj0909@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystatin C level (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2017.