- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03144011
Acute Kidney Injury in Children After Cardiopulmonary Bypass
Early Diagnosis of Acute Kidney Injury in Children With Congenital Heart Disease After Cardiopulmonary Bypass
Acute kidney injury (AKI) is a common complication in patients with congenital heart defects after cardiopulmonary bypass. The death rate from AKI in critically ill children remains high and reaches 60%.
The basic criteria for diagnosing and assessing the severity of kidney injury until recently were the level of serum creatinine and the amount of urine released. However, it should be noted that the level of serum creatinine, traditionally used to assess renal function, does not significantly increase until a decrease of more than 50% of the glomerular filtration rate, in addition, its level depends also on some extrarenal causes. Artificial blood circulation and hemodilution leads to the preservation of the level of creatinine at sufficiently low levels up to 1-3 days postoperative period. The level of diuresis as well as the level of creatinine is a nonspecific criterion after cardiac surgery and depends on several factors.
Currently, in the field of acute renal injury studies, progress has been made in the emergence of new biomarkers such as the tissue inhibitor metalloproteinase-2 (TIMP-2) and insulin-like growth factor binding globulin-7 (IGFBP7), which are early markers of acute renal damage. In a study in adult patients, it was shown that the levels of TIMP-2 and IGFBP7 increased In the first 24-48 before the diagnosis of IR-associated renal damage.
Among pediatric patients with congenital heart defects, such studies are single and only present for the age group 3 and older, which also demonstrated the high specificity and prognostic significance of these biomarkers in the early diagnosis of acute renal damage.
It should also be noted that, in spite of the high specificity of the markers described, it is also necessary to note their considerable cost.
Thus, taking into account the above, it is planned to compare and identify the relationship of these indicators with such parameter as the index of renal vascular resistance, the increase of which in the pre- and postoperative period may serve as a sign of the beginning acute renal injury.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Novosibirsk Region
-
Novosibirsk, Novosibirsk Region, Den russiske føderasjonen, 630055
- Siberian Biomedical Research Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
Age from 1 month to 1 year Presence of congenital heart disease Radical correction of the defect in conditions of cardiopulmonary bypass
Exclusion Criteria:
Inconsistency with age criteria Cardiotonic support before surgery Acute renal, acute liver failure before surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
acute renal injury on the scale pRIFLE
Tidsramme: 48 hours
|
diagnosis of acute kidney injury after cardiac surgery
|
48 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
TIMP-2
Tidsramme: 6 hours
|
elevation of TIMP-2 after cardiac surgery
|
6 hours
|
|
renal resistant index with doppler ultrasound
Tidsramme: before, 6 hour, 24 hour
|
with doppler ultrasound
|
before, 6 hour, 24 hour
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20.03 №194
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Kardiopulmonal bypass
-
Università Vita-Salute San RaffaeleFullførtHjertekirurgi | Koronararterie-bypass-grafting | Aortokoronar bypassKroatia, Italia, Kina, Malaysia, Den russiske føderasjonen, Portugal, Bahrain, Brasil, Bulgaria, Tsjekkia, Egypt, Saudi-Arabia, Serbia
-
Nanjing First Hospital, Nanjing Medical UniversityFullførtKardiopulmonal bypass | Koronararterie-bypass-graftingKina
-
Cairo UniversityPåmelding etter invitasjonKoronararterie-bypass-grafting | Post koronar bypass podingEgypt
-
Queen Mary University of LondonRekrutteringKoronar bypass | CABG | Ventilkirurgi | Koronar bypass-graft | Kardiovaskulær | Utskifting av ventil | Koronararterie Bypass Graft Surgery (CABG)Storbritannia
-
Mayo ClinicFullførtRoux-en-Y Gastric Bypass | Gastrisk bypass | Bariatrisk kirurgiForente stater
-
University of EdinburghNHS LothianRekrutteringKoronar bypass | Koronar bypass-graft | Graftfeil | Koronararterie Bypass Graft Surgery (CABG)Storbritannia
-
Region SkaneFullførtKardiopulmonal bypass | Peroperativ myokardskade | Kardioplegi | Koronar arterie bypass graft (CABG)Sverige
-
The Medicines CompanyFullførtKardiopulmonal bypass | Koronar bypass-graft
-
Lawson Health Research InstituteMedtronicFullførtKardiopulmonal bypass | Koronar bypass kirurgiCanada
-
Kartal Kosuyolu Yuksek Ihtisas Education and Research...Trakya University Faculty of Medicine HospitalFullførtHjertekirurgi | Desfluran | Kardiopulmonal bypass | Koronar bypass-graftkirurgi | Hjerne natriuretisk peptid | Utfall