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

Acute Kidney Injury Clinical Trial

— DIADSORBMAB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02533609
• Other study ID #: 2015-02-ENDVERSION
• Status: Active, not recruiting
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Bacterial Infection
• Bacterial Infections

Locations

Country	Name	City	State
Germany	Prof. Kindgen-Milles	Duesseldorf

Sponsors (2)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf	Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d)	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
Primary	Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD	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