Citrate Anticoagulation for Postdilution Hemofiltration (CIPOHA)

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Acute Kidney Injury
• Intervention / Treatment: Other: renal replacement therapy as clinically indicated

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
    • Contact: Kindgen-Milles, MD; Phone Number: 07049 +49 211 81; Email: kindgen-milles@med.uni-duesseldorf.de
    • Principal Investigator: Detlef Kindgen-Milles, Prof.
    • Sub-Investigator: Timo Brandenburger, PD Dr. med.
    • Sub-Investigator: Thomas Dimski, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients at ICU with acute kidney injury

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filter running time	Filterlifetime with regional citrate anticoagulation for haemofiltration	72 hours

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Diamed GmbH, Cologne, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: 2018-82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No