NCT03969966

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

May 29, 2019

Last Update Submit

May 7, 2020

Conditions

Acute Kidney InjuryCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Filter running time

    Filterlifetime with regional citrate anticoagulation for haemofiltration

    72 hours

Interventions

renal replacement therapy as clinically indicatedOTHER

Continuous renal replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients at ICU with acute kidney injury

You may qualify if:

  • acute kidney injury
  • critical illness and treatment at ICU

You may not qualify if:

  • age \< 18 years
  • pregnancy or breast feeding
  • severe lactate acidosis ( \> 10 mmol/l) for longer than 6 hours and pH \< 7.2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38982339DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

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

May 29, 2019

First Posted

May 31, 2019

Study Start

January 14, 2019

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

May 11, 2020

Record last verified: 2020-05

Locations

DE(1)