An explorative study determining the hepatic cyst penetration of antibiotics (ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam) and factors affecting penetration.

Conditions: hepatic cyst
polycystic liver disease
10019654

Registration Number: NL-OMON46163

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age >=18 years
- Indication for aspiration and sclerotherapy (large symptomatic liver cyst)
- Providing informed consent

Exclusion Criteria

- History of hypersensitivity to multiple antibiotics, making it impossible to include the patient in one of two treatment groups.
- Use of other drugs with a contra-indication for antibiotic use, making it impossible to include the patient in one of two treatment groups.
- Presence of an arterio-venous fistula, history of mastectomy or lymph node dissection at both extremities.
- Signs of phlebitis, defined as localized skin redness and swelling, at both extremities
- 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.
- Severe renal impairment (eGFR < 30 ml/min/1,73 m2)
- Use of antibiotics that are going to be administered for the study in the 7 days before aspiration sclerotherapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the hepatic cyst penetration of<br /><br>ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam, defined<br /><br>as the ratio (%) of cyst aspirate concentration (mg/ml) to blood plasma<br /><br>concentration (mg/ml). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Plasma concentration curve, consisting of 6 measurements (every 1.5 hours) in<br /><br>blood plasma.<br /><br>• Cyst parameters.<br /><br>• Cyst fluid biochemical analysis (protein, albumin, haemocytometrics,<br /><br>bilirubin, pH)<br /><br>• Blood biochemical analysis (protein, albumin, haemocytometrics, bilirubin,<br /><br>creatinine)<br /><br>• Demographic information, medical history, concomitant medication<br /><br>• Complications or adverse events</p><br>