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A Predictive Score System for AKI Following Pediatric Cardiac Surgery

4. august 2022 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100037
        • Rekruttering
        • Fuwai Hospital
        • Kontakt:
          • Jianhui Wang, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 sekund til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

A cohort of pediatric patients of 18 years old and younger who have cardiac procedures in Fuwai Hospital, Beijing, China will be consecutively enrolled.

Beskrivelse

Inclusion Criteria:

  1. < 18 years old
  2. Pediatric patients undergoing cardiac surgery in Fuwai Hospital

Exclusion Criteria:

  1. Supported by dialysis for renal failure prior to cardiac procedure
  2. Previously received a renal transplant
  3. Lack of preoperative or postoperative serum creatinine measurements
  4. Guardians' refusal on informed consent sign

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
AKI
AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
Andet: Ingen indgriben
Ingen indgriben
No-AKI
No-AKI is defined by KDIGO criterion based on peri-operative serum creatinine variation.
Andet: Ingen indgriben
Ingen indgriben

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Prevalence of Acute Kidney Injury
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of dialysis
Tidsramme: Up to postoperative 7 days
The therapeutic approach to correct renal failure
Up to postoperative 7 days
The hours of mechanical ventilation
Tidsramme: Up to postoperative 7 days
Time before first extubation
Up to postoperative 7 days
The incidence of reinbutation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The relative change of left ventricular ejection fraction (LVEF) from baseline to postoperative 1 year
Tidsramme: 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
Tidsramme: Up to postoperative 1 year
(LVEDD at 1 year - LVEDD at baseline)/LVEDD at baseline * 100%
Up to postoperative 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China National Center for Cardiovascular Diseases

Efterforskere

  • Ledende efterforsker: Jianhui Wang, MD, Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medial Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2022

Primær færdiggørelse (Forventet)

30. maj 2023

Studieafslutning (Forventet)

30. juni 2023

Datoer for studieregistrering

Først indsendt

11. marts 2022

Først indsendt, der opfyldte QC-kriterier

4. august 2022

Først opslået (Faktiske)

5. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-LC15

Plan for individuelle deltagerdata (IPD)

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IPD-planbeskrivelse

IPD cannot be shared with other researchers. However, data can be provided if requested.

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