Penetration of Cefazolin Into Hepatic Cysts

Hepatic Cyst Clinical Trial

— PENTAC  

Official title:

An Explorative Study Determining the Hepatic Cyst Penetration of Cefazolin and Factors Affecting Penetration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368015
• Other study ID #: NL49426.091.14
• Status: Completed
• Phase: N/A
• First received: December 29, 2014
• Last updated: February 2, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cysts
• Hepatic Cyst

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Center; Department of Gastroenterology & Hepatology	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic cyst penetration of cefazolin defined as the ratio (%) of cyst aspirate concentration (µg/ml) to serum concentration (µg/ml) of cefazolin.		Intraoperative	No
Secondary	Segmental location (I-VIII) of hepatic cyst		Baseline	No
Secondary	Volume (mL) of hepatic cyst		Baseline	No
Secondary	Blood parameter: total protein (g/l)		Intraoperative	No
Secondary	Blood parameter: albumin (g/l)		Intraoperative	No
Secondary	Blood parameter: urea (mmol/l)		Intraoperative	No
Secondary	Blood parameter: white blood cell count (*10^9/l)		Intraoperative	No
Secondary	Blood parameter: white blood differentiation (%)		Intraoperative	No
Secondary	Blood parameter: CRP (mg/l)		Intraoperative	No
Secondary	Blood parameter: direct bilirubin (µmol/L)		Intraoperative	No
Secondary	Blood parameter: total bilirubin (µmol/L)		Intraoperative	No
Secondary	Blood parameter: CA 19.9 (E/ml)		Intraoperative	No
Secondary	Blood parameter: creatinine (µmol/L)		Intraoperative	No
Secondary	Cyst fluid parameter: total protein (g/l)		Intraoperative	No
Secondary	Cyst fluid parameter: albumin (g/l)		Intraoperative	No
Secondary	Cyst fluid parameter: urea (mmol/l)		Intraoperative	No
Secondary	Cyst fluid parameter: white blood cell count (*10^9/l)		Intraoperative	No
Secondary	Cyst fluid parameter: white blood cell differentiation (%)		Intraoperative	No
Secondary	Cyst fluid parameter: CRP (mg/l)		Intraoperative	No
Secondary	Cyst fluid parameter: direct bilirubin (µmol/L)		Intraoperative	No
Secondary	Cyst fluid parameter: total bilirubin (µmol/L)		Intraoperative	No
Secondary	Cyst fluid parameter: CA 19.9 (E/ml)		Intraoperative	No
Secondary	Cyst fluid parameter: sodium (mmol/l)		Intraoperative	No
Secondary	Cyst fluid parameter: pH		Intraoperative	No
Secondary	Number of patients that develop clinical signs indicating aspiration sclerotherapy-induced cyst infection		Until four weeks after aspiration sclerotherapy	No
Secondary	Number of participants with adverse events		until four weeks after aspiration sclerotherapy	Yes