Congenital Heart DiseaseNCT04030481
Effects of Anesthetic Techniques on Renal Function
An observational study of Congenital Heart Disease and Acute Kidney Injury, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children. Read more about this study
- Who is it for?
- Ages 1 minute to 3 years
- Conditions the study is for
- Congenital Heart Disease, Acute Kidney Injury
- What is being tested?
- inhalation anesthesia and Total intravenous anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Sep 2019
- Phase
- Observational
- 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 1 minute to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: After approved by the ethics committee, sixty patients who met the inclusion criteria of this study with their parents' informed consent in Children's Hospital of Fudan University.
Who may be able to join
- children with congenital heart disease
- <3 years of age
Who cannot join
- preoperative renal insufficiency;
- renal malformation, kidney absence
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: Different Effects of Two Anesthetic Techniques on Renal Function During the Perioperative Period of Cardiac Surgery in Children
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
Read the detailed description
Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.
- Conditions
- Congenital Heart Disease, Acute Kidney Injury
- Being tested
- inhalation anesthesia, Total intravenous anesthesia
- Keywords
- propofol,sevoflurane
- Medical subject headings
- Heart Defects, Congenital, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhalation anesthesiaOther
sevoflurane was used to maintain anesthesia
Total intravenous anesthesiaOther
propofol was used to maintain anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sevoflurane, sufentanil and rocuronium | sevoflurane (1-3%)and sufentanil (0.5-2 mcg/kg/h) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required Receives: Other: inhalation anesthesia | |
| Group B: Propofol, sufentanil and rocuronium | propofol (4-12 mg/kg/h) and sufentanil (0.5-2 mcg/kg/h/) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required Receives: Other: Total intravenous anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal blood flow
Changes of blood flow information of renal artery was obtained before anesthesia induction, after anesthesia, at the end of operation and 24 hours after surgery, unit(cm/s)
Measured: 2 days
Secondary outcomes (4)
neutrophil gelatinase-associated lipocalin , NGAL
Changes of blood NGAL were obtained before and 2 hours after surgery, unit(ng/ml)
Measured: 2 days
creatinine
Changes of creatinine before and 3 days after acquisition, unit (mmol/L)
Measured: 3 and 4 days
Mean arterial pressure
Mean arterial pressure synchronized with renal blood flow was recorded, unit (mmHg)
Measured: 2 days
cardiopulmonary bypass (CPB) time
Cardiopulmonary bypass time was recorded, unit(minutes)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mazhong zhang, MD, Study director, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030481
- Sponsor's protocol ID
- DEOTATORFDTPPOCSIC
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2019
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Effects of Two Anesthetic Techniques on Renal Function During the Perioperative Period of Cardiac Surgery in Children
- ClinicalTrials.gov ID
- NCT04030481
- Acronym / sponsor ID
- DEOTATORFDTPPOCSIC
- Conditions
- Congenital Heart Disease, Acute Kidney Injury
- Keywords
- propofol,sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 24 Jul 2019 (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.
This study evaluates Different effects of two anesthetic techniques on renal function during the perioperative period of cardiac surgery in children.
Detailed description
Acute kidney injury is one of the major complications after heart surgery, which increases the mortality of patients. Therefore, early prevention and detection of acute kidney injury is particularly important. In recent years, more and more studies have shown that both sevoflurane, an inhaled anesthetic widely used in clinical practice, and propofol, an intravenous anesthetic, have protective effects on kidneys. The aim of this study was to investigate the perioperative effects of two different anesthetic techniques on renal function for pediatric cardiac surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Sevoflurane, sufentanil and rocuronium | – | Other: inhalation anesthesiasevoflurane (1-3%)and sufentanil (0.5-2 mcg/kg/h) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required |
| Group B: Propofol, sufentanil and rocuronium | – | Other: Total intravenous anesthesiapropofol (4-12 mg/kg/h) and sufentanil (0.5-2 mcg/kg/h/) and rocuronium (0.3～0.6mg/kg/h) used intraoperatively as required |
Who may qualify
- Ages
- 1 minute to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- After approved by the ethics committee, sixty patients who met the inclusion criteria of this study with their parents' informed consent in Children's Hospital of Fudan University.
Key inclusion criteria (2 listed)
- children with congenital heart disease
- <3 years of age
Key exclusion criteria (2 listed)
- preoperative renal insufficiency;
- renal malformation, kidney absence
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 |
|---|---|---|
| inhalation anesthesiasevoflurane was used to maintain anesthesia | Other | Group A: Sevoflurane, sufentanil and rocuronium |
| Total intravenous anesthesiapropofol was used to maintain anesthesia | Other | Group B: Propofol, sufentanil and rocuronium |
Primary outcome
renal blood flow
Time frame: 2 days
Changes of blood flow information of renal artery was obtained before anesthesia induction, after anesthesia, at the end of operation and 24 hours after surgery, unit(cm/s)
4 secondary outcomes
neutrophil gelatinase-associated lipocalin , NGAL
Time frame: 2 days
creatinine
Time frame: 3 and 4 days
Mean arterial pressure
Time frame: 2 days
cardiopulmonary bypass (CPB) time
Time frame: 24 hours
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 Oct 2026.
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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.
mazhong zhang, MD study director
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Acute Kidney Injury, run by Children's Hospital of Fudan 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 2 inclusion and 2 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 Oct 2026. 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. 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?
renal blood flow (time frame: 2 days). 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 26 Oct 2026.