hepatic cyst polycystic liver disease
Conditions
Interventions
Group 1: intravenous piperacillin/tazobactam (4000/500 mg) in combination with
ciprofloxacin (400 mg) .
Group 2: intravenous co-trimoxazole (960 mg) in combination with doxycycline
(200 mg).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years - Indication for aspiration and sclerotherapy (large symptomatic liver cyst) - Providing informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the hepatic cyst penetration of ciprofloxacin, co-trimoxazole, doxycycline and piperacillin/tazobactam, defined as the ratio (%) of cyst aspirate concentration (mg/ml) to blood plasma concentration (mg/ml). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Plasma concentration curve, consisting of 6 measurements (every 1.5 hours) in blood plasma. • Cyst parameters. • Cyst fluid biochemical analysis (protein, albumin, haemocytometrics, bilirubin, pH) • Blood biochemical analysis (protein, albumin, haemocytometrics, bilirubin, creatinine) • Demographic information, medical history, concomitant medication • Complications or adverse events | — |
Countries
Netherlands
Outcome results
None listed