Acute Kidney InjuryNCT02888275
Dexmedetomidine in Pediatric Cardiac Surgery
A study testing Dexmedetomidine and normal saline in people with Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Dexmedetomidine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Aug 2018
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients undergoing congenital cardiac surgery
Who cannot join
- history of allergy or anaphylaxis to study drug
- preexisting renal dysfunction (preoperative creatinine >1.5mg/dl)
- diabetes
- liver profile abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery
Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.
Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.
The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.
- Conditions
- Acute Kidney Injury
- Being tested
- Dexmedetomidine, normal saline
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| DEX | Experimental | dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr. Receives: Drug: Dexmedetomidine |
| no_DEX | Active comparator | Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
daily check the laboratory parameter.
Measured: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Secondary outcomes (2)
glomerular filtration rate
daily check the laboratory parameter.
Measured: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Urine output
daily check the laboratory parameter.
Measured: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888275
- Sponsor's protocol ID
- H1608-052-784
- Status last verified
- Jul 2020
- First submitted
- 30 Aug 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02888275
- Acronym / sponsor ID
- H1608-052-784
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Sep 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.
Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.
Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.
The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX | Experimental | Drug: Dexmedetomidinedexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr. |
| no_DEX | Active comparator | Drug: normal salineNormal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients undergoing congenital cardiac surgery
Key exclusion criteria (4 listed)
- history of allergy or anaphylaxis to study drug
- preexisting renal dysfunction (preoperative creatinine >1.5mg/dl)
- diabetes
- liver profile abnormality
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 |
|---|---|---|
| Dexmedetomidine | Drug | DEX |
| normal saline | Drug | no_DEX |
Primary outcome
serum creatinine
Time frame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
daily check the laboratory parameter.
2 secondary outcomes
glomerular filtration rate
Time frame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Urine output
Time frame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 normal saline in people with Acute Kidney Injury, run by Seoul National University Hospital 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (time frame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.). 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 28 Jul 2020.