Penetration of Cefazolin Into Hepatic Cysts

NCT ID: NCT02368015

Last Updated: 2016-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-01-31

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.

Conditions

Hepatic Cyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Peripheral intravenous cannula (IVC)

Intervention Type: OTHER

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

cefazolin

Intervention Type: DRUG

Interventions

Peripheral intravenous cannula (IVC)

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Intervention Type: OTHER

cefazolin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL49426.091.14

Identifier Type: -

Identifier Source: org_study_id