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ISRCTN
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ISRCTN14198655
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ClinicalTrials.gov identifier
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Public title
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Predrainage administration of Dopamine in the Renal function of selected patients with Obstructive Jaundice
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Scientific title
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Predrainage administration of dopamine associated with fluid administration improved renal function in selected patients with obstructive jaundice: a prospective randomised study
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Acronym
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DROJ
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Serial number at source
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N/A
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Study hypothesis
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No studies have been carried out to evaluate the effects of dopamine in obstructive jaundice (OJ) patients on the renal and endocrine derangements observed in these patients before biliary drainage or surgery. The present study was therefore designed to analyse the effect of dopamine associated with fluid administration on extracellular water (ECW), water and sodium regulating hormones and renal function alterations in patients with OJ undergoing endoscopic internal biliary drainage.
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Lay summary
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Ethics approval
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Hospital Reina Sofia Clinical Trials and Ethics Committee approved in March 2005 (ref: PIO-20155)
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Study design
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Prospective randomised controlled study
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Obstructive jaundice
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Participants - inclusion criteria
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1. Malignant OJ with serum bilirubin higher than 6 mg/dl
2. Ultrasound evidence of extrahepatic and intrahepatic bile duct dilation (more than 8 mm and 4 mm respectively)
3. Feasibility of internal endoscopic biliary drainage
4. Aged 35 to 76 years, either sex
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Participants - exclusion criteria
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1. Cholangitis
2. Acute pancreatitis
3. Heart disease
4. Arterial hypertension
5. Chronic lung disease
6. Use of diuretics
7. Chronic renal failure
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Anticipated start date
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10/01/2007
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Anticipated end date
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21/06/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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Two treatment groups were created according to whether patients received dopamine at 3 mg/Kg/min or not, associated with 3000 ml of saline solution for 48 hours before biliary drainage in addition to their regular hospital ward diet. For the post-drainage study, patients treated with dopamine prior to biliary drainage, will be randomised according to whether they continue with dopamine for 72 hours or not. All patients will be kept under the same conditions. After endoscopic internal drainage, patients will fast for the first 12 hours and 2500 ml of glucosaline solution containing 150 mEq of NaCl will be administrated until the following morning. On the second day, the intravenous infusion will be stopped and patients will receive a 2000 kcal/day diet for up to 72 hours when the study protocol will finish. Billiary drainage is considered successful if total bilirubin decreases by at least 30% and aerobilia with reduction of the common bile duct diameter demonstrated by ultrasound 72 hours after the procedure.
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Primary outcome measure(s)
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Renal function (CrCl), assessed at admission, before drainage, as well as 24 hours and 72 hours after biliary drainage.
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Secondary outcome measure(s)
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Assessed at admission, before drainage, as well as 24 hours and 72 hours after biliary drainage:
1. Extracellular water (ECW) volume
2. Serum leves of aldosterone, renin, atrial natriuretic peptide (ANP), antidiuretic hormone (ADH), endothelin-1 (ET-1)
3. Urine prostaglandin E2 (PgE2)
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Sources of funding
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Spanish Ministry of Health (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (ref: PIO-20155)
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Trial website
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Publications
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Contact name
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Prof
Javier
Padillo
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Address
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Imperio Argentina 43
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City/town
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Cordoba
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Zip/Postcode
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14014
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Country
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Spain
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Sponsor
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Reina Sofia University Hospital (Spain)
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Address
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Avda. Menéndez Pidal S/N
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City/town
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Cordoba
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Zip/Postcode
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14004
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Country
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Spain
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Sponsor website:
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http://www.juntadeandalucia.es/servicioandaluzdesalud/hrs2/
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Date applied
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08/01/2010
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Last edited
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15/01/2010
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Date ISRCTN assigned
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15/01/2010
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