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

NCT02533609 | Unknown

• 1 other identifier: 2015-02-ENDVERSION
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
2. 2.whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h

Conditions

Acute Kidney Injury; Bacterial Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation

You may qualify if:

• Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation
• Age \> 18 y

You may not qualify if:

• \< 18 y
• Pregnancy
• Contraindications against citrate-anticoagulation or continous renal replacement therapy

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Fresenius Medical Care Deutschland GmbH: collaborator

Study Sites (1)

Prof. Kindgen-Milles

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury; Bacterial Infections

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections and Mycoses; Infections

Study Officials

• Detlef Kindgen-Milles, Prof.

  Department of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. D. Kindgen-Milles

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 27, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 11, 2020

Record last verified: 2020-05

Locations

DE (1)