Citrate Anticoagulation for Postdilution Hemofiltration | NCT03969966

Studies
Citrate Anticoagulation for Postdilution Hemofiltration

NCT03969966

Sponsor

Heinrich-Heine University, Duesseldorf

Status

Unknown status

Last Update Posted

May 11, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Acute Kidney Injury
Critical Illness

Interventions

renal replacement therapy as clinically indicated

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jul 31, 2021Estimated

First Submitted Date

May 29, 2019

First Submission Date that Met QC Criteria

May 29, 2019

First Posted Date

May 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2020

Last Update Posted Date

May 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klinik für Anästhesiologie, Prof. Dr. D. Kindgen-Milles, Heinrich-Heine University, DuesseldorfPrincipal Investigator

Lead Sponsor

Heinrich-Heine University, DuesseldorfOTHER

Collaborators

Name	Class
Diamed GmbH, Cologne, Germany	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
renal replacement therapy as clinically indicated	Other	Continuous renal replacement therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients at ICU with acute kidney injury

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf	Recruiting	Düsseldorf		40225	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38982339	Derived	Dimski T, Brandenburger T, Vollmer C, Kindgen-Milles D. A safe and effective protocol for postdilution hemofiltration with regional citrate anticoagulation. BMC Nephrol. 2024 Jul 9;25(1):218. doi: 10.1186/s12882-024-03659-y.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D058186	Acute Kidney Injury
D016638	Critical Illness