Penetration of Cefazolin Into Hepatic Cysts

NCT02368015 | Completed

• 1 other identifier: NL49426.091.14
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Penetration; Cefazolin; Hepatic cyst

Outcome Measures

Primary Outcomes (1)

• Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.

  Intraoperative

Secondary Outcomes (25)

• 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

Study Arms (1)

Patients with a large hepatic cyst

OTHER

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

Interventions

Peripheral intravenous cannula (IVC) OTHER

Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).

Patients with a large hepatic cyst

cefazolin DRUG

Patients with a large hepatic cyst

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: February 20, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

NL (1)