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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03969966
Other study ID # 2018-82
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 14, 2019
Est. completion date July 31, 2021

Study information

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

Clinical Trial Summary

This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.


Description:

Acute kidney injury (AKI) requiring continuous renal replacement therapy (CCRT occurs in approx. 15 % of all intensive care patients. A sustained and prolonged filter running time is required to deliver an effective dialysis dose. This requires effective anticoagulation. Today, regional citrate anticoagulation (RCA) is preferred over systemic anticoagulation because of prolonged filter lifetimes and less adverse effects.

We here study prospectively patients with AKI who are treated with continuous veno-venous haemofiltration using an RCA protocol.

We will evaluate all parameters of CRRT including filter running times, delivered dialysis dose, causes for treatment interruption and control of pH and electrolytes.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute kidney injury

- critical illness and treatment at ICU

Exclusion Criteria:

- age < 18 years

- pregnancy or breast feeding

- severe lactate acidosis ( > 10 mmol/l) for longer than 6 hours and pH < 7.2

Study Design


Related Conditions & MeSH terms


Intervention

Other:
renal replacement therapy as clinically indicated
Continuous renal replacement therapy

Locations

Country Name City State
Germany Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Duesseldorf

Sponsors (2)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf Diamed GmbH, Cologne, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Filter running time Filterlifetime with regional citrate anticoagulation for haemofiltration 72 hours
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