Acute Kidney InjuryNCT02599155
The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
A study testing Crystalloid and Colloid in people with Acute Kidney Injury, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Crystalloid and Colloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Mar 2016
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged less than 7 years old
- American Society of Anesthesiology (ASA) physical status 1-3
Who cannot join
- Preoperative creatinine > 1.5mg/dl
- History of dialysis
- Liver function abnormality
- Diabetes Mellitus
- History of allergic reaction
- Coagulation abnormality
Trial locations and contacts
1 site in 1 country.
About this study
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.
Read the detailed description
The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.
- Conditions
- Acute Kidney Injury
- Being tested
- Crystalloid, Colloid
- Keywords
- crystalloid, colloid, children, infant, cardiac surgery
- 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.
CrystalloidDrug
Also called normal saline
normal saline administration for volume expansion in hypovolemic status
ColloidDrug
Also called HES 130/0.4
HES 130/0.4 administration for volume expansion in hypovolemic status
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid group | Placebo comparator | Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups. Receives: Drug: Crystalloid |
| Colloid group | Active comparator | Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups. Receives: Drug: Colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Measured: From the day of surgery to postoperative 7 days
Secondary outcomes (4)
Blood loss
Measured: From the day of surgery to postoperative 7 days
Transfusion amount
Measured: From the day of surgery to postoperative 7 days
Mechanical ventilation time
Measured: From the day of surgery to postoperative 7 days
Length of ICU stay
Measured: From the day of surgery to postoperative 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionMar 2016
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 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 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
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599155
- Sponsor's protocol ID
- H1507-061-687
- Status last verified
- Jun 2017
- First submitted
- 3 Nov 2015
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Oh HW, Lee JH, Kim HC, Kim EH, Song IK, Kim HS, Kim JT. The effect of 6% hydroxyethyl starch (130/0.4) on acute kidney injury in paediatric cardiac surgery: a prospective, randomised trial. Anaesthesia. 2018 Feb;73(2):205-215. doi: 10.1111/anae.14129. Epub 2017 Nov 17.
PubMed 29150842
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02599155
- Acronym / sponsor ID
- H1507-061-687
- Conditions
- Acute Kidney Injury
- Keywords
- crystalloid, colloid, children, infant, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Nov 2015 (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.
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.
Detailed description
The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid group | Placebo comparator | Drug: CrystalloidCrystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups. |
| Colloid group | Active comparator | Drug: ColloidColloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged less than 7 years old
- American Society of Anesthesiology (ASA) physical status 1-3
Key exclusion criteria (6 listed)
- Preoperative creatinine > 1.5mg/dl
- History of dialysis
- Liver function abnormality
- Diabetes Mellitus
- History of allergic reaction
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 |
|---|---|---|
| CrystalloidAlso: normal salinenormal saline administration for volume expansion in hypovolemic status | Drug | Crystalloid group |
| ColloidAlso: HES 130/0.4HES 130/0.4 administration for volume expansion in hypovolemic status | Drug | Colloid group |
Primary outcome
Acute Kidney Injury
Time frame: From the day of surgery to postoperative 7 days
4 secondary outcomes
Blood loss
Time frame: From the day of surgery to postoperative 7 days
Transfusion amount
Time frame: From the day of surgery to postoperative 7 days
Mechanical ventilation time
Time frame: From the day of surgery to postoperative 7 days
Length of ICU stay
Time frame: From the day of surgery to postoperative 7 days
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 26 Jun 2017.
- Derived from this study: PubMed 29150842Oh HW, Lee JH, Kim HC, Kim EH, Song IK, Kim HS, Kim JT. The effect of 6% hydroxyethyl starch (130/0.4) on acute kidney injury in paediatric cardiac surgery: a prospective, randomised trial. Anaesthesia. 2018 Feb;73(2):205-215. doi: 10.1111/anae.14129. Epub 2017 Nov 17.
- 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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid and Colloid 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 2 inclusion and 6 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 26 Jun 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 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?
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?
Acute Kidney Injury (time frame: From the day of surgery to postoperative 7 days). 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 NCT02599155, 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 26 Jun 2017.