Trial Outcomes & Findings for Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED) (NCT NCT02287493)

NCT ID: NCT02287493

Last Updated: 2021-12-14

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 35 participants
• Primary outcome timeframe: days receiving SLED, up to 5 days
• Results posted on: 2021-12-14

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	19	16
Overall Study COMPLETED	19	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

Baseline characteristics by cohort

Measure	Meropenem n=19 Participants Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.	Ceftazidim n=16 Participants Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.	Total n=35 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	63 years n=7 Participants	64.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Germany	19 participants n=5 Participants	16 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Meropenem n=19 Participants Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Ceftazidim n=16 Participants Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) Trough level > MIC	19 Participants	16 Participants
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC) Trough level < MIC	0 Participants	0 Participants

SECONDARY outcome

Timeframe: minimum duration of hospital stay, maximum 1 year

ICU mortality

Outcome measures

Measure	Meropenem n=19 Participants Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Ceftazidim n=16 Participants Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Mortality	9 Participants	9 Participants

SECONDARY outcome

Timeframe: minimum duration of hospital stay, maximum 1 year

Length of stay at the ICU and in hospital

Outcome measures

Measure	Meropenem n=19 Participants Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Ceftazidim n=16 Participants Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Length of Stay (LOS) LOS in ICU	36 days Interval 8.0 to 264.0	67 days Interval 12.0 to 264.0
Length of Stay (LOS) LOS in hospital	56 days Interval 24.0 to 264.0	90 days Interval 15.0 to 264.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Meropenem n=19 Participants Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Ceftazidim n=16 Participants Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Number of Patients With Clinical Cure of Infections	10 Participants	9 Participants

Adverse Events

Meropenem

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ceftazidim

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christina König

University Medical Center Hamburg-Eppendorf

Phone: +49 040 7410 -0

Email: ch.koenig@uke.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place