Condition category
Digestive System
Date applied
08/01/2010
Date assigned
15/01/2010
Last edited
15/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Javier Padillo

ORCID ID

Contact details

Imperio Argentina 43
Cordoba
14014
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Predrainage administration of dopamine associated with fluid administration improved renal function in selected patients with obstructive jaundice: a prospective randomised study

Acronym

DROJ

Study hypothesis

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.

Ethics approval

Hospital Reina Sofia Clinical Trials and Ethics Committee approved in March 2005 (ref: PIO-20155)

Study design

Prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obstructive jaundice

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Dopamine

Primary outcome measures

Renal function (CrCl), assessed at admission, before drainage, as well as 24 hours and 72 hours after biliary drainage.

Secondary outcome measures

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)

Overall trial start date

10/01/2007

Overall trial end date

21/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Cholangitis
2. Acute pancreatitis
3. Heart disease
4. Arterial hypertension
5. Chronic lung disease
6. Use of diuretics
7. Chronic renal failure

Recruitment start date

10/01/2007

Recruitment end date

21/06/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Imperio Argentina 43
Cordoba
14014
Spain

Sponsor information

Organisation

Reina Sofia University Hospital (Spain)

Sponsor details

Avda. Menéndez Pidal S/N
Cordoba
14004
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.juntadeandalucia.es/servicioandaluzdesalud/hrs2/

Funders

Funder type

Government

Funder name

Spanish Ministry of Health (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (ref: PIO-20155)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes