NCT02600416

Brief Summary

The aim of this study is to determine the effects of AV port reversal (AVPR) on recirculation, clearance, post-filter ionized calcium and subsequently citrate dosing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 15, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

October 15, 2015

Last Update Submit

March 28, 2018

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

  • change in citrate concentration in circuit after AV port reversal

    8 hours

  • change in post-filter ionised Ca after AV port reversal

    8 hours

  • change in clearance after AV port reversal

    8 hours

Study Arms (1)

AV port reversal

OTHER

Patients undergoing citrate CVVH.

Other: AV port reversal

Interventions

AV port reversalOTHER

Reversal of the AV port at 1h Reversal of the AV port to start position at 7h

AV port reversal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill patients requiring CRRT for AKI (RIFLE criteria)
  • Written informed consent from the patient or legal representative
  • Diuresis is minimal or the patient is anuric so that effects of changes in clearance as a consequence of diuresis are minimalized and do not influence study outcomes.
  • The patient has undergone CVVH for a number of days, ensuring good metabolic control, so that possible short term loss of clearance as a consequence of AV port reversal has no detrimental effects.

You may not qualify if:

  • pre-existing chronic renal insufficiency requiring dialysis
  • chronic immunosuppression
  • liver cirrhosis Child-Pugh C
  • severe or shock-related hepatitis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Willem Boer, MD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 15, 2015

First Posted

November 9, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

BE(1)