- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Rafael C Miranda, Physician
- Telefonnummer: 55 - 17 32015054
- E-post: rafacmiranda@gmail.com
Studera Kontakt Backup
- Namn: Maurício N Machado, Physician
- Telefonnummer: 55 - 17 32164025
- E-post: maunmac@gmail.com
Studieorter
-
-
São Paulo
-
São José do Rio Preto, São Paulo, Brasilien, 15090000
- Rekrytering
- Hospital de Base - São José do Rio preto Medical School
-
Kontakt:
- Maurício N Machado, Physician
- Telefonnummer: 55 17 32164025
- E-post: maunmac@gmail.com
-
Huvudutredare:
- Rafael C Miranda, Physician
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
AKI group
Acute kidney injury group after cardiac surgery.
|
NKF group
Normal kidney function group after cardiac surgery
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Evaluate the urinary excretion of NGAL as a marker of early development of acute kidney injury in patients undergoing cardiac surgery
Tidsram: 96 hours
|
96 hours
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Emerson quintino, Hospital de Base
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAAE 0246.0.000.140-07
- 1411 - 2007.
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