A Predictive Score System for AKI Following Pediatric Cardiac Surgery
4 augusti 2022 uppdaterad av: Jianhui Wang, China National Center for Cardiovascular Diseases
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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
2000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jianhui Wang, MD
- Telefonnummer: +86-010-88398082;
- E-post: stewenwang@sina.com
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100037
- Rekrytering
- Fuwai Hospital
-
Kontakt:
- Jianhui Wang, M.D.
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 sekund till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.
Beskrivning
Inclusion Criteria:
- < 18 years old
- Pediatric patients undergoing cardiac surgery in Fuwai Hospital
Exclusion Criteria:
- 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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
AKI
AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
|
Inget ingripande
|
|
No-AKI
No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
|
Inget ingripande
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Prevalence of Acute Kidney Injury
Tidsram: 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.
|
Up to postoperative 7 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The incidence of dialysis
Tidsram: Up to postoperative 7 days
|
The therapeutic approach to correct renal failure
|
Up to postoperative 7 days
|
|
The hours of mechanical ventilation
Tidsram: Up to postoperative 7 days
|
Time before first extubation
|
Up to postoperative 7 days
|
|
The incidence of reinbutation
Tidsram: Up to hospital discharge, an average of 7 days
|
Need for postoperative endotracheal intubation given the occurrence of respiratory or non-respiratory complication after extubation.
|
Up to hospital discharge, an average of 7 days
|
|
The incidence of tracheotomy
Tidsram: Up to hospital discharge, an average of 7 days
|
The necessary treatment for postoperative respiratory failure
|
Up to hospital discharge, an average of 7 days
|
|
The incidence of re-operation
Tidsram: Up to hospital discharge, an average of 7 days
|
Re-exploration prescribed by surgeons due to cardiac issues or excessive chest drainage volume.
|
Up to hospital discharge, an average of 7 days
|
|
The incidence of mechanical cardiac support
Tidsram: Up to hospital discharge, an average of 7 days
|
Supported by extracorporeal membrane oxygenation from operative day to discharge or death
|
Up to hospital discharge, an average of 7 days
|
|
The incidence of mortality
Tidsram: Up to hospital discharge, an average of 7 days
|
Specific death reason
|
Up to hospital discharge, an average of 7 days
|
|
The incidence of pulmonary infection
Tidsram: Up to hospital discharge, an average of 7 days
|
Assessed by relevant guidelines of pulmonary infection
|
Up to hospital discharge, an average of 7 days
|
|
The cost of medical resources
Tidsram: Up to hospital discharge, an average of 7 days
|
The RMB patients spend during the whole hospitalization
|
Up to hospital discharge, an average of 7 days
|
|
Intensive Care Unit Discharge Time
Tidsram: Up to ICU discharge, an average of 5 days
|
Time and date when the patient is transferred to ward
|
Up to ICU discharge, an average of 5 days
|
|
Hospital Discharge Time
Tidsram: Up to hospital discharge, an average of 7 days
|
Time and date when the patient is discharged from the hospital
|
Up to hospital discharge, an average of 7 days
|
|
The relative change of left ventricular ejection fraction (LVEF) from baseline to hospital discharge
Tidsram: Up to hospital discharge, an average of 7 days
|
(LVEF at hospital discharge - LVEF at baseline)/LVEF at baseline * 100%
|
Up to hospital discharge, an average of 7 days
|
|
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to hospital discharge
Tidsram: Up to hospital discharge, an average of 7 days
|
(LVEDD at hospital discharge - LVEDD at baseline)/LVEDD at baseline * 100%
|
Up to hospital discharge, an average of 7 days
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year
Tidsram: Up to postoperative 1 year
|
(LVEF at 1 year - LVEF at baseline)/LVEF at baseline * 100%
|
Up to postoperative 1 year
|
|
The relative change of left ventricular end-diastolic diameter (LVEDD) from baseline to postoperative 1 year
Tidsram: Up to postoperative 1 year
|
(LVEDD at 1 year - LVEDD at baseline)/LVEDD at baseline * 100%
|
Up to postoperative 1 year
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Jianhui Wang, MD, Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2022
Primärt slutförande (Förväntat)
30 maj 2023
Avslutad studie (Förväntat)
30 juni 2023
Studieregistreringsdatum
Först inskickad
11 mars 2022
Först inskickad som uppfyllde QC-kriterierna
4 augusti 2022
Första postat (Faktisk)
5 augusti 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 augusti 2022
Senast verifierad
1 augusti 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021-LC15
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
IPD cannot be shared with other researchers.
However, data can be provided if requested.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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