Replacement Therapy, Renal
Conditions
Brief summary
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Detailed description
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: * mortality * length of stay at the intensive care unit (ICU) and hospital * clinical cure of infections Inclusion criteria: * age: \> 18 years * patients under SLED * antiinfective treatment exclusion criteria: \- missing informed consent
Interventions
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age: 18 or older * patients receiving SLED and either meropenem or ceftazidim
Exclusion criteria
* missing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | days receiving SLED, up to 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | minimum duration of hospital stay, maximum 1 year | ICU mortality |
| Length of Stay (LOS) | minimum duration of hospital stay, maximum 1 year | Length of stay at the ICU and in hospital |
| Number of Patients With Clinical Cure of Infections | minimum duration of hospital stay, maximum 1 year | Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meropenem Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. | 19 |
| Ceftazidim Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | Meropenem | Ceftazidim | Total |
|---|---|---|---|
| Age, Continuous | 66 years | 63 years | 64.5 years |
| Region of Enrollment Germany | 19 participants | 16 participants | 35 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: days receiving SLED, up to 5 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Meropenem | Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Trough level > MIC | 19 Participants |
| Meropenem | Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Trough level < MIC | 0 Participants |
| Ceftazidim | Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Trough level < MIC | 0 Participants |
| Ceftazidim | Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) | Trough level > MIC | 16 Participants |
Secondary
Length of Stay (LOS)
Length of stay at the ICU and in hospital
Time frame: minimum duration of hospital stay, maximum 1 year
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Meropenem | Length of Stay (LOS) | LOS in hospital | 56 days |
| Meropenem | Length of Stay (LOS) | LOS in ICU | 36 days |
| Ceftazidim | Length of Stay (LOS) | LOS in hospital | 90 days |
| Ceftazidim | Length of Stay (LOS) | LOS in ICU | 67 days |
Secondary
Mortality
ICU mortality
Time frame: minimum duration of hospital stay, maximum 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meropenem | Mortality | 9 Participants |
| Ceftazidim | Mortality | 9 Participants |
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
Time frame: minimum duration of hospital stay, maximum 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Meropenem | Number of Patients With Clinical Cure of Infections | 10 Participants |
| Ceftazidim | Number of Patients With Clinical Cure of Infections | 9 Participants |