Predrainage administration of Dopamine in the Renal function of selected patients with Obstructive Jaundice
| ISRCTN | ISRCTN14198655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14198655 |
| Protocol serial number | N/A |
| Sponsor | Reina Sofia University Hospital (Spain) |
| Funder | Spanish Ministry of Health (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (ref: PIO-20155) |
- Submission date
- 08/01/2010
- Registration date
- 15/01/2010
- Last edited
- 15/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Javier Padillo
Scientific
Scientific
Imperio Argentina 43
Cordoba
14014
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Predrainage administration of dopamine associated with fluid administration improved renal function in selected patients with obstructive jaundice: a prospective randomised study |
| Study acronym | DROJ |
| Study objectives | 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(s) | Hospital Reina Sofia Clinical Trials and Ethics Committee approved in March 2005 (ref: PIO-20155) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Dopamine |
| Primary outcome measure(s) |
Renal function (CrCl), assessed at admission, before drainage, as well as 24 hours and 72 hours after biliary drainage. |
| Key secondary outcome measure(s) |
Assessed at admission, before drainage, as well as 24 hours and 72 hours after biliary drainage: |
| Completion date | 21/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/01/2007 |
| Date of final enrolment | 21/06/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Imperio Argentina 43
Cordoba
14014
Spain
14014
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
