Penetration of Cefazolin Into Hepatic Cysts
- Conditions
- Hepatic Cyst
- Interventions
- Other: Peripheral intravenous cannula (IVC)
- Registration Number
- NCT02368015
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
Hepatic cysts are fluid-filled cavities located in the liver parenchyma. They are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. Aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. Spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. Evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. To prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. In this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. We hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Age ≥18 years
- Indication for aspiration and sclerotherapy
- Providing informed consent
- Presence of an arteriovenous fistula, history of mastectomy or lymph node dissection at both extremities
- Signs of phlebitis, defined as localized skin redness and swelling, at both extremities
- History of cephalosporin and/or penicillin allergy consisting of IgE-mediated reactions as anaphylaxis, angioedema, urticaria.
- Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with a large hepatic cyst Peripheral intravenous cannula (IVC) During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care. In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints. Patients with a large hepatic cyst cefazolin During this study all subjects undergo aspiration sclerotherapy and receive antibiotic prophylaxis with a single dose of cefazolin (intravenous infusion 1000mg) following standard care. In order to secure patient safety and allow accurate measurement of cefazolin concentrations, an additional peripheral intravenous cannula (IVC) will be placed to allow blood withdrawal at three timepoints.
- Primary Outcome Measures
Name Time Method Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin. Intraoperative
- Secondary Outcome Measures
Name Time Method Segmental location (I-VIII) of hepatic cyst Baseline Volume (mL) of hepatic cyst Baseline Blood parameter: total protein (g/l) Intraoperative Blood parameter: albumin (g/l) Intraoperative Blood parameter: urea (mmol/l) Intraoperative Blood parameter: white blood cell count (*10^9/l) Intraoperative Blood parameter: white blood differentiation (%) Intraoperative Blood parameter: CRP (mg/l) Intraoperative Blood parameter: direct bilirubin (µmol/L) Intraoperative Blood parameter: total bilirubin (µmol/L) Intraoperative Blood parameter: CA 19.9 (E/ml) Intraoperative Blood parameter: creatinine (µmol/L) Intraoperative Cyst fluid parameter: total protein (g/l) Intraoperative Cyst fluid parameter: albumin (g/l) Intraoperative Cyst fluid parameter: urea (mmol/l) Intraoperative Cyst fluid parameter: white blood cell count (*10^9/l) Intraoperative Cyst fluid parameter: white blood cell differentiation (%) Intraoperative Cyst fluid parameter: CRP (mg/l) Intraoperative Cyst fluid parameter: direct bilirubin (µmol/L) Intraoperative Cyst fluid parameter: total bilirubin (µmol/L) Intraoperative Cyst fluid parameter: CA 19.9 (E/ml) Intraoperative Cyst fluid parameter: sodium (mmol/l) Intraoperative Cyst fluid parameter: pH Intraoperative Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection Until four weeks after aspiration sclerotherapy Number of participants with adverse events until four weeks after aspiration sclerotherapy
Trial Locations
- Locations (1)
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
🇳🇱Nijmegen, Gelderland, Netherlands