Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis

• Conditions: Bacterial Infection; Acute Kidney Injury

• Registration Number: NCT02533609
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

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

1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se

2. whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2015-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-11
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD	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
Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)	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

Trial Locations

Locations (1)

Prof. Kindgen-Milles; 🇩🇪 Duesseldorf, Germany