An interventional study of Peripheral intravenous cannula (IVC) and cefazolin in Hepatic Cyst, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-03.
Sponsored by Radboud University Medical Center · Not applicable and Interventional
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.
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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.
Other: Peripheral intravenous cannula (IVC) · Drug: cefazolin
Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).
Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.
Time frame: Intraoperative
Segmental location (I-VIII) of hepatic cyst
Time frame: Baseline
Volume (mL) of hepatic cyst
Time frame: Baseline
Blood parameter: total protein (g/l)
Time frame: Intraoperative
Blood parameter: albumin (g/l)
Time frame: Intraoperative
Blood parameter: urea (mmol/l)
Time frame: Intraoperative
Blood parameter: white blood cell count (*10^9/l)
Time frame: Intraoperative
Blood parameter: white blood differentiation (%)
Time frame: Intraoperative
Blood parameter: CRP (mg/l)
Time frame: Intraoperative
Blood parameter: direct bilirubin (µmol/L)
Time frame: Intraoperative
Blood parameter: total bilirubin (µmol/L)
Time frame: Intraoperative
Blood parameter: CA 19.9 (E/ml)
Time frame: Intraoperative
Blood parameter: creatinine (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: total protein (g/l)
Time frame: Intraoperative
Cyst fluid parameter: albumin (g/l)
Time frame: Intraoperative
Cyst fluid parameter: urea (mmol/l)
Time frame: Intraoperative
Cyst fluid parameter: white blood cell count (*10^9/l)
Time frame: Intraoperative
Cyst fluid parameter: white blood cell differentiation (%)
Time frame: Intraoperative
Cyst fluid parameter: CRP (mg/l)
Time frame: Intraoperative
Cyst fluid parameter: direct bilirubin (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: total bilirubin (µmol/L)
Time frame: Intraoperative
Cyst fluid parameter: CA 19.9 (E/ml)
Time frame: Intraoperative
Cyst fluid parameter: sodium (mmol/l)
Time frame: Intraoperative
Cyst fluid parameter: pH
Time frame: Intraoperative
Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection
Time frame: Until four weeks after aspiration sclerotherapy
Number of participants with adverse events
Time frame: until four weeks after aspiration sclerotherapy
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cefazolin
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