- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02533609
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis (DIADSORBMAB)
Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
- whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Duesseldorf, Tyskland, 40225
- Prof. Kindgen-Milles
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
- Age > 18 y
Exclusion Criteria:
- < 18 y
- Pregnancy
- Contraindications against citrate-anticoagulation or continous renal replacement therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Piperacillin/Tazobactam
Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics
|
|
Imipenem/Cilastatin
Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)
Tidsramme: up to three days
|
Total hemofilter clearance (ml/min) of imipenem/cilastatin and piperacillin/tazobactam on each treatment day during an 8-hour dosing interval using blood sided clearance - Total amount of antibiotic drug which is eliminated via the filter during 24 h using filter clearance and delivered dialysis dose during 24 h |
up to three days
|
|
Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD
Tidsramme: up to three days
|
Filter patency is calculated as a function of the sieving coefficient for small solutes (i.e.
creatinine and the respective antibiotic drugs) over the first 72 h, Sieving coefficient is without dimension
|
up to three days
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Detlef Kindgen-Milles, Prof., Department of Anesthesiology
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-02-ENDVERSION
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