Determination of Pharmacokinetic Parameters of Amphotericin B in critically ill patients during continuous veno-venous haemodiafiltration.

Conditions: Critically ill patients with systemic fungal infection.

Registration Number: EUCTR2009-010943-15-IE

Lead Sponsor: Intensive Care Unit, The Adelaide and Meath Hospital Incorporating the National Children's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

All patients admitted to the ICU and who are in receipt of Abelcet or Ambisome as part of their ICU treatment.
Patients over 18 years old

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient under 18 years old, patient/relative refusal, analyst (research investigator) refusal on the basis of patient carrying known serious infectious disease e.g. Hepatitis B or HIV.

Children under 16
Adults with learning disabilities
Adults who have a terminal illness
Those who could be considered to be vulnerable or have a particularly dependent
relationship with the investigator, e.g. medical students

Women of child bearing age will be included, all will have a pregnancy test and pregnant women will be excluded

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate pharmacokinetic parameters of Amphotericin B in critically ill patients undergoing continuous veno-venous haemodiafiltration (CVVHDF) and identify any difference between pharmacokinetic parameters in patients on CVVHDF and not on CVVHDF.;Secondary Objective: ;Primary end point(s): Determination of Vd and Cl from the AUC and Cmax of Amphotericin B, as either Abelcet or Ambisome, in critically ill patients. These values are to be determined from the measured Amphotericin B concentrations in the blood samples taken for the purpose of the study. <br>Evaluation of this pharmacokinetic data to determine whether the CVVHDF, as used in the study population, affects these parameters. <br>

Secondary Outcome Measures