Congenital Heart DiseaseNCT05489263
A Predictive Score System for AKI Following Pediatric Cardiac Surgery
An observational study of Congenital Heart Disease and Surgery--Complications, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Congenital Heart Disease, Surgery--Complications, Acute Kidney Injury
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Jun 2023
- 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 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.
Who may be able to join
- < 18 years old
- Pediatric patients undergoing cardiac surgery in Fuwai Hospital
Who cannot join
- Supported by dialysis for renal failure prior to cardiac procedure
- Previously received a renal transplant
- Lack of preoperative or postoperative serum creatinine measurements
- Guardians' refusal on informed consent sign
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Jianhui Wang, M.D.
About this study
Official title: Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery
Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. However, how to precisely identify those who have greater hazard to encounter postoperative AKI seems ambiguous.
Read the detailed description
The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.
Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.
At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.
This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.
- Being tested
- No intervention
- Keywords
- Pediatric Cardiac Surgery, Acute Kidney Injury, Prediction
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| AKI | AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. Receives: Other: No intervention | |
| No-AKI | No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of Acute Kidney Injury
Acute Kidney Injury was defined by Kidney Disease Improving Global Outcomes (KDIGO) Criteria. Accordingly, AKI was classified as stage 1, stage 2 and stage 3.
Measured: Up to postoperative 7 days
Secondary outcomes (13)
The incidence of dialysis
The therapeutic approach to correct renal failure
Measured: Up to postoperative 7 days
The hours of mechanical ventilation
Time before first extubation
Measured: Up to postoperative 7 days
The incidence of reinbutation
Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
Measured: Up to hospital discharge, an average of 7 days
The incidence of tracheotomy
The necessary treatment for postoperative respiratory failure
Measured: Up to hospital discharge, an average of 7 days
The incidence of re-operation
Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.
Measured: Up to hospital discharge, an average of 7 days
The incidence of mechanical cardiac support
Supported by extracorporeal membrane oxygenation from operative day to discharge or death
Measured: Up to hospital discharge, an average of 7 days
The incidence of mortality
Specific death reason
Measured: Up to hospital discharge, an average of 7 days
The incidence of pulmonary infection
Assessed by relevant guidelines of pulmonary infection
Measured: Up to hospital discharge, an average of 7 days
The cost of medical resources
The RMB patients spend during the whole hospitalization
Measured: Up to hospital discharge, an average of 7 days
Intensive Care Unit Discharge Time
Time and date when the patient is transferred to ward
Measured: Up to ICU discharge, an average of 5 days
Hospital Discharge Time
Time and date when the patient is discharged from the hospital
Measured: Up to hospital discharge, an average of 7 days
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge
(LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline * 100%
Measured: Up to hospital discharge, an average of 7 days
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge
(LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline * 100%
Measured: Up to hospital discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Apr 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 Jun 2023 (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 Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianhui Wang, China National Center for Cardiovascular Diseases
- Investigators
- Jianhui Wang, MD, Principal investigator, Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489263
- Sponsor's protocol ID
- 2021-LC15
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be shared with other researchers. However, data can be provided if requested.
Publications
Bie D, Li Y, Wang H, Liu Q, Dou D, Jia Y, Yuan S, Li Q, Wang J, Yan F. Relationship between intra-operative urine output and postoperative acute kidney injury in paediatric cardiac surgery: A retrospective observational study. Eur J Anaesthesiol. 2024 Dec 1;41(12):881-888. doi: 10.1097/EJA.0000000000002044. Epub 2024 Aug 16.
PubMed 39021216
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Validation of A Predictive Score System for Acute Kidney Injury Following Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05489263
- Acronym / sponsor ID
- 2021-LC15
- Keywords
- Pediatric Cardiac Surgery, Acute Kidney Injury, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
Acute kidney injury (AKI) has been recognized as a typical post- operative complication among the children undergoing surgical repair of a congenital cardiac defect. It is associated with increased morbidity and mortality in the intensive care unit and a higher utilization of hospital resources. However, how to precisely identify those who have greater hazard to encounter postoperative AKI seems ambiguous.
Detailed description
The development of AKI is common following cardiac surgery whether in adult or pediatric population. Not only severe AKI like dialysis support, but also mild kidney injury has profound influence on increased subsequent morbidities and mortality.
Pediatric patients who undergo cardiac procedures are characterized by lower weight, younger age, complicated cardiac anomaly and poor resistance to surgical insults. Thus, in comparison with adults, their AKI risk is relatively higher.
At present there has been no specific intervention regarding AKI prevention and therapy. Establishing a risk score based on patient characteristics and surgical information to effectively predict postoperative AKI risk is therefore imperative. It can serve as a decision-making tool to facilitate patient management with regard to kidney prognosis.
This program is aimed at developing and internally validating a AKI risk score post cardiac surgery in a Chinese pediatric population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Other: No interventionAKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. |
| No-AKI | – | Other: No interventionNo-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation. |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.
Key inclusion criteria (2 listed)
- < 18 years old
- Pediatric patients undergoing cardiac surgery in Fuwai Hospital
Key exclusion criteria (4 listed)
- Supported by dialysis for renal failure prior to cardiac procedure
- Previously received a renal transplant
- Lack of preoperative or postoperative serum creatinine measurements
- Guardians' refusal on informed consent sign
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 |
|---|---|---|
| No interventionNo intervention | Other | AKI, No-AKI |
Primary outcome
The Prevalence of Acute Kidney Injury
Time frame: Up to postoperative 7 days
Acute Kidney Injury was defined by Kidney Disease Improving Global Outcomes (KDIGO) Criteria. Accordingly, AKI was classified as stage 1, stage 2 and stage 3.
13 secondary outcomes
The incidence of dialysis
Time frame: Up to postoperative 7 days
The hours of mechanical ventilation
Time frame: Up to postoperative 7 days
The incidence of reinbutation
Time frame: Up to hospital discharge, an average of 7 days
The incidence of tracheotomy
Time frame: Up to hospital discharge, an average of 7 days
The incidence of re-operation
Time frame: Up to hospital discharge, an average of 7 days
The incidence of mechanical cardiac support
Time frame: Up to hospital discharge, an average of 7 days
The incidence of mortality
Time frame: Up to hospital discharge, an average of 7 days
The incidence of pulmonary infection
Time frame: Up to hospital discharge, an average of 7 days
The cost of medical resources
Time frame: Up to hospital discharge, an average of 7 days
Intensive Care Unit Discharge Time
Time frame: Up to ICU discharge, an average of 5 days
Hospital Discharge Time
Time frame: Up to hospital discharge, an average of 7 days
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge
Time frame: Up to hospital discharge, an average of 7 days
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge
Time frame: Up to hospital discharge, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 39021216Bie D, Li Y, Wang H, Liu Q, Dou D, Jia Y, Yuan S, Li Q, Wang J, Yan F. Relationship between intra-operative urine output and postoperative acute kidney injury in paediatric cardiac surgery: A retrospective observational study. Eur J Anaesthesiol. 2024 Dec 1;41(12):881-888. doi: 10.1097/EJA.0000000000002044. Epub 2024 Aug 16.
- Individual participant dataSharing planned: No. IPD cannot be shared with other researchers. However, data can be provided if requested.
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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.
Jianhui Wang, MD principal investigator
Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
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 Surgery--Complications, run by China National Center for Cardiovascular Diseases 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 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhui Wang, MD (+86-010-88398082;, stewenwang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence of Acute Kidney Injury (time frame: Up 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 NCT05489263, 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 5 Aug 2022.