Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).
Primary endpoint:
- Plasma levels of antiinfectives during SLED
Secondary endpoints:
Inclusion criteria:
exclusion criteria:
- missing informed consent
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meropenem | Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. |
| |
| Ceftazidim | Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic Analysis | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains. | days receiving SLED, up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | ICU mortality | minimum duration of hospital stay, maximum 1 year |
| Length of Stay (LOS) | Length of stay at the ICU and in hospital |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Kluge, Prof. Dr. | University Medical Center Hamburg-Eppendorf, Department of Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29382394 | Derived | Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Meropenem | Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. |
| FG001 | Ceftazidim | Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Meropenem | Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. |
| BG001 | Ceftazidim | Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains. | Posted | Count of Participants | Participants | days receiving SLED, up to 5 days |
|
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Mortality was not considered to be a Serious Adverse Event.
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Mortality was not considered to be a Serious Adverse Event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Meropenem | Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina König | University Medical Center Hamburg-Eppendorf | +49 040 7410 -0 | ch.koenig@uke.de |
Not provided
Not provided
Not provided
Not provided
| minimum duration of hospital stay, maximum 1 year |
| Number of Patients With Clinical Cure of Infections | Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support | minimum duration of hospital stay, maximum 1 year |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis |
|
|
| Secondary | Mortality | ICU mortality | Posted | Count of Participants | Participants | minimum duration of hospital stay, maximum 1 year |
|
|
|
| Secondary | Length of Stay (LOS) | Length of stay at the ICU and in hospital | Posted | Median | Inter-Quartile Range | days | minimum duration of hospital stay, maximum 1 year |
|
|
|
| Secondary | Number of Patients With Clinical Cure of Infections | Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support | Posted | Count of Participants | Participants | minimum duration of hospital stay, maximum 1 year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ceftazidim | Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided