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ISRCTN
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ISRCTN75232398
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ClinicalTrials.gov identifier
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Public title
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Randomised study with ciprofloxacine in acute pancreatitis
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Scientific title
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A double-blind, placebo-controlled trial of ciprofloxacin prophylaxis in patients with acute necrotising pancreatitis
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Acronym
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CIPRONAP
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Serial number at source
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CGD001/98
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Study hypothesis
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Our aim was to assess the effects of intravenous prophylactic ciprofloxacin in the incidence of infected necrosis and mortality in patients with necrotising pancreatitis, compared to a control population.
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Ethics approval
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Ethics approval received from the Ethics Committee of the L'Hospitalet de Llobregat (Spain) on the 12th December 1998 (ref: 129/98).
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Study design
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Prospective, randomised, placebo-controlled, double blind 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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Acute pancreatitis
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Participants - inclusion criteria
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All adult patients of either sex:
1. Without previous antibiotic treatment
2. With detectable pancreatic necrosis in a contrast-enhanced computed tomography (CT) scan 25 performed within 48 - 72 hours of admission
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Participants - exclusion criteria
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1. Antibiotic allergy
2. Clinical evidence of sepsis on admission
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Anticipated start date
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01/05/1999
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Anticipated end date
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31/12/2003
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Status of trial
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Completed
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Patient information material
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Target number of participants
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80
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Interventions
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All patients with acute pancreatitis suspected to have the severe form of the disease underwent a dynamic contrast-enhanced CT scanning within 48 - 72 hours of admission. When the CT showed a pancreatic necrosis patients signed a written consent, and were randomly assigned to receive one of the below:
1. Prophylactic antibiotic treatment: 300 mg ciprofloxacin every 12 hours for 10 days (n = 22)
2. Placebo (n = 19)
All patients were treated medically on admission (aggressive fluid resuscitation along with electrolyte imbalance, complete avoidance of oral intake, pain control and total parenteral nutrition). Patients with organ failure were followed in the intensive care unit (ICU). When infected necrosis was clinically suspected, a CT-guided fine-needle aspiration (FNA) followed by a Gram stain and a bacteriologic culture was carried out. If infection could be diagnosed through these procedures, we indicated surgical treatment. Further indications for surgery were: diagnostic doubt, organ failure despite intensive medical treatment and symptomatic sterile necrosis (defined as persistent abdominal pain or inability to eat after 4 to 6 weeks of medical management).
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Primary outcome measure(s)
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To determine whether prophylaxis with intravenous ciprofloxacin could reduce the incidence of infected pancreatic necrosis.
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Secondary outcome measure(s)
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Effects on:
1. Mortality rate
2. Extra-pancreatic infections
3. Surgical treatment, its timing and the re-operation rate
4. Development of organ failure 2
5. In-hospital as well as intensive care unit (ICU) length of stay
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Sources of funding
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Bellvitge Hospital (Spain)
No grant nor payment from the pharmaceutical industry.
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Trial website
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Publications
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Contact name
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Prof
Eduardo
Jaurrieta
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Address
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Joan Fabregat
Servei de Cirurgia General i Digestiva,
Unitat Cirurgia Hepatobilio-Pancreàtica i Trasplantament Hepàtic
Hospitalet de Llobregat
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City/town
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Barcelona
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Zip/Postcode
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08907
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Country
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Spain
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Sponsor
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Hospital Universitari De Bellvitge (Spain)
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Address
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Feixa Llarga S.N.
Hopsitalet de Llobregat
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City/town
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Barcelona
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Zip/Postcode
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08907
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Country
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Spain
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Sponsor website:
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http://www.csub.scs.es
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Date applied
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04/02/2008
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Last edited
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16/04/2008
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Date ISRCTN assigned
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16/04/2008
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