Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration (ABx-CVVHDF)
Drugmonitoring of Antiinfective Drugs in Patients Receiving Continous Veno-venous Hemodiafiltration
Approximately 300 patients have to be enrolled in the study. They are followed up until the end of ICU stay. Usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making CVVHDF necessary. After enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. The analysis results are sent back to the study team at the Charité - Universitätsmedizin Berlin and enable them to optimize antiinfectiva treatment of the study patients.
Data are used to test calculation tools and modify them if necessary.
연구 개요
상세 설명
Little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. Drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy.
To achieve our study goal we plan:
- To measure serum-concentrations of antiinfective drugs applied to the patients
- To measure concentrations of antiinfective drugs in hemofiltration fluids.
- To compare the actual measured concentrations with concentration predicted in known calculation tools.
- To modify these calculation tools if necessary for better prediction.
연구 유형
연락처 및 위치
연구 장소
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Berlin, 독일, 10117
- Medical Department, Division of Nephrology, Campus Charité Mitte, Charité - Universitätsmedizin Berlin
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Heidenheim, 독일, 89522
- Pharmacy, Kliniken Landkreis Heidenheim gGmbH
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Male and female patients, age ≥ 18 years
- Patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs
Exclusion Criteria:
- Pregnancy and lactation period.
- Participation in a clinical intervention study
- Lacking willingness to save and hand out data within the study
- Accommodation in an institution due to an official or judicial order
- The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
- Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Intensive care unit patients needing renal replacement therapy
Male and female patients in the intensive care unit (ICU), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Antibiotic clearance (l/h)
기간: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
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Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
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2차 결과 측정
결과 측정 |
기간 |
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28-day mortality
기간: The 28-days mortality will be assessed on the 28th study day
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The 28-days mortality will be assessed on the 28th study day
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ABx-CVVHDF
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