- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00594919
Neutrophil Gelatinase-Associated Lipocalin: Biomarker of Acute Kidney Injury After Cardiac Surgery
Neutrophil Gelatinase-Associated Lipocalin(NGAL): Early Biomarker of Acute Kidney Injury After Cardiac Surgery
Studieoversikt
Status
Forhold
Detaljert beskrivelse
All patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and / or valve replacement, in need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU, will be candidates for participation in this study.
Criteria for exclusion Patients with IRA before hospitalization in the ICU; Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml / min; Patients transplanted kidney; Patients with chronic renal failure on dialysis; Patients anuric the admission in the ICU; Refusal to participate in the study.
Definition of IRA:
IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours (Annex 1).
Laboratory Investigations Samples of urine will be collected before surgery, after 2, 4, 6, 12, 24, 48, 72 and 96 hours after the end of the CEC for determination of creatinine and urinary NGAL (normalization of NGAL for excretion urinary creatinine).
The serum creatinine is measured before surgery and daily during the first 4 days after surgery for the diagnosis of IRA. If the time of CEC exceed 2 hours, the first sample of urine after the end of the CEC will be considered as "sample 2 hours".
Quantification of NGAL Samples of urine will be centrifuged (5 min at 2000 rpm) and frozen at -20 ° C for later determination of NGAL by method of ELISA (Kit commercial AntybodyShop, Denmark).
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Rafael C Miranda, Physician
- Telefonnummer: 55 - 17 32015054
- E-post: rafacmiranda@gmail.com
Studer Kontakt Backup
- Navn: Maurício N Machado, Physician
- Telefonnummer: 55 - 17 32164025
- E-post: maunmac@gmail.com
Studiesteder
-
-
São Paulo
-
São José do Rio Preto, São Paulo, Brasil, 15090000
- Rekruttering
- Hospital de Base - São José do Rio preto Medical School
-
Ta kontakt med:
- Maurício N Machado, Physician
- Telefonnummer: 55 17 32164025
- E-post: maunmac@gmail.com
-
Hovedetterforsker:
- Rafael C Miranda, Physician
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients aged greater than 18 years undergoing elective cardiac surgery for coronary artery bypass grafting and/or valve replacement
- In need of cardiopulmonary bypass and with the prospect of minimum hospital length stay of 48 hours in ICU
Exclusion Criteria:
- Patients with IRA before hospitalization in the ICU
- Patients with estimated glomerular filtration (MDRD formula simplified) less than 30 ml/min
- Patients transplanted kidney
- Patients with chronic renal failure on dialysis
- Patients anuric the admission in the ICU
- Refusal to participate in the study.
Definition of IRA:
IRA will be defined according to the new proposal of AKIN (Acute Kidney Injury Network) (awaiting publication): abrupt elevation (48 hours) of serum creatinine in value greater than or equal to 0.3 mg / dL or an increase of 50% compared to baseline or reduction of urinary volume to 0.5 ml / kg / h for more than 6 hours
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
AKI group
Acute kidney injury group after cardiac surgery.
|
NKF group
Normal kidney function group after cardiac surgery
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery
Tidsramme: 96 hours
|
96 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Emerson quintino, Hospital de Base
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
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
- CAAE 0246.0.000.140-07
- 1411 - 2007.
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