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Penetration of Cefazolin Into Hepatic Cysts (PENTAC)

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ClinicalTrials.gov Identifier: NCT02368015
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatic Cyst Other: Peripheral intravenous cannula (IVC) Drug: cefazolin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Patients with a large hepatic cyst

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)
Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Drug: cefazolin


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Segmental location (I-VIII) of hepatic cyst [ Time Frame: Baseline ]
  2. Volume (mL) of hepatic cyst [ Time Frame: Baseline ]
  3. Blood parameter: total protein (g/l) [ Time Frame: Intraoperative ]
  4. Blood parameter: albumin (g/l) [ Time Frame: Intraoperative ]
  5. Blood parameter: urea (mmol/l) [ Time Frame: Intraoperative ]
  6. Blood parameter: white blood cell count (*10^9/l) [ Time Frame: Intraoperative ]
  7. Blood parameter: white blood differentiation (%) [ Time Frame: Intraoperative ]
  8. Blood parameter: CRP (mg/l) [ Time Frame: Intraoperative ]
  9. Blood parameter: direct bilirubin (µmol/L) [ Time Frame: Intraoperative ]
  10. Blood parameter: total bilirubin (µmol/L) [ Time Frame: Intraoperative ]
  11. Blood parameter: CA 19.9 (E/ml) [ Time Frame: Intraoperative ]
  12. Blood parameter: creatinine (µmol/L) [ Time Frame: Intraoperative ]
  13. Cyst fluid parameter: total protein (g/l) [ Time Frame: Intraoperative ]
  14. Cyst fluid parameter: albumin (g/l) [ Time Frame: Intraoperative ]
  15. Cyst fluid parameter: urea (mmol/l) [ Time Frame: Intraoperative ]
  16. Cyst fluid parameter: white blood cell count (*10^9/l) [ Time Frame: Intraoperative ]
  17. Cyst fluid parameter: white blood cell differentiation (%) [ Time Frame: Intraoperative ]
  18. Cyst fluid parameter: CRP (mg/l) [ Time Frame: Intraoperative ]
  19. Cyst fluid parameter: direct bilirubin (µmol/L) [ Time Frame: Intraoperative ]
  20. Cyst fluid parameter: total bilirubin (µmol/L) [ Time Frame: Intraoperative ]
  21. Cyst fluid parameter: CA 19.9 (E/ml) [ Time Frame: Intraoperative ]
  22. Cyst fluid parameter: sodium (mmol/l) [ Time Frame: Intraoperative ]
  23. Cyst fluid parameter: pH [ Time Frame: Intraoperative ]
  24. Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection [ Time Frame: Until four weeks after aspiration sclerotherapy ]
  25. Number of participants with adverse events [ Time Frame: until four weeks after aspiration sclerotherapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Indication for aspiration and sclerotherapy
  • Providing informed consent

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368015


Locations
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Netherlands
Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02368015    
Other Study ID Numbers: NL49426.091.14
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Radboud University Medical Center:
Penetration
Cefazolin
Hepatic cyst
Additional relevant MeSH terms:
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Cysts
Neoplasms
Pathological Conditions, Anatomical
 Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents