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

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Completed
• CT.gov ID: NCT02287493
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Actual Duration (Months): 41
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Replacement Therapy, Renal	Other: Pharmacokinetic Analysis

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

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Meropenem Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.	Other: Pharmacokinetic Analysis
Ceftazidim Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.	Other: Pharmacokinetic Analysis

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Mortality [minimum duration of hospital stay, maximum 1 year]

   ICU mortality

2. Length of Stay (LOS) [minimum duration of hospital stay, maximum 1 year]

   Length of stay at the ICU and in hospital

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age: 18 or older

• patients receiving SLED and either meropenem or ceftazidim

Exclusion Criteria:

• missing informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

• Principal Investigator: Stefan Kluge, Prof. Dr., University Medical Center Hamburg-Eppendorf, Department of Intensive Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PD Dr. rer. medic. Claudia Langebrake, Head Clinical Research Hospital Pharmacy, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT02287493
• Other Study ID Numbers: PV4244
• First Posted: Nov 10, 2014
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2021

Study Results

Participant Flow

Arm/Group Title	Meropenem	Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
Period Title: Overall Study
STARTED	19	16
COMPLETED	19	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Meropenem	Ceftazidim	Total
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.	Total of all reporting groups
Overall Participants	19	16	35
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	66	63	64.5
Sex: Female, Male (Count of Participants)
Female	5 26.3%	10 62.5%	15 42.9%
Male	14 73.7%	6 37.5%	20 57.1%
Region of Enrollment (participants) [Number]
Germany	19 100%	16 100%	35 100%

Outcome Measures

1. Primary Outcome

Title	Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meropenem	Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Measure Participants	19	16
Trough level < MIC	0 0%	0 0%
Trough level > MIC	19 100%	16 100%

2. Secondary Outcome

Title	Mortality
Description	ICU mortality
Time Frame	minimum duration of hospital stay, maximum 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meropenem	Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics. Pharmacokinetic Analysis	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics. Pharmacokinetic Analysis
Measure Participants	19	16
Count of Participants [Participants]	9 47.4%	9 56.3%

3. Secondary Outcome

Title	Length of Stay (LOS)
Description	Length of stay at the ICU and in hospital
Time Frame	minimum duration of hospital stay, maximum 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meropenem	Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
Measure Participants	19	16
LOS in hospital	56	90
LOS in ICU	36	67

4. Secondary Outcome

Title	Number of Patients With Clinical Cure of Infections
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meropenem	Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed	Adult ICU patients receiving ceftazidim during SLED will be analyzed
Measure Participants	19	16
Count of Participants [Participants]	10 52.6%	9 56.3%

Adverse Events

Time Frame	Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Mortality was not considered to be a Serious Adverse Event.
Adverse Event Reporting Description	Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. Mortality was not considered to be a Serious Adverse Event.
Arm/Group Title	Meropenem		Ceftazidim
Arm/Group Description	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.		Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
All Cause Mortality
	Meropenem		Ceftazidim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Meropenem		Ceftazidim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Meropenem		Ceftazidim
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.