Citrate Anticoagulation for Postdilution Hemofiltration (CIPOHA)

May 7, 2020 updated by: Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany, 40225
        • Recruiting
        • Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
        • Contact:
        • Principal Investigator:
          • Detlef Kindgen-Milles, Prof.
        • Sub-Investigator:
          • Timo Brandenburger, PD Dr. med.
        • Sub-Investigator:
          • Thomas Dimski, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

Diamed GmbH, Cologne, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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