The CIRE Study (CItrate REcirculation Study)

Acute Kidney Injury Clinical Trial

— CIRE  

Official title:

Effects of AV Port Reversal in Citrate CVVH - The CIRE Study (CItrate REcirculation Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600416
• Other study ID #: CIRE study
• Status: Completed
• Phase: N/A
• First received: October 15, 2015
• Last updated: March 28, 2018
• Start date: December 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: March 2018
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Rationale:

AV port reversal (AVPR) has been demonstrated to increase recirculation in venous catheters used in ICU for CVVH. The effects of this frequently used manoeuvre have not been described in the setting of CVVH using regional citrate anticoagulation.

Objective:

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

Study design and methods:

Open trial studying the effect of AVPR in patients undergoing citrate CVVH. After measurement in standard catheter configuration, AVPR is performed after which effects on catheter recirculation, clearance, citrate dosing and post-filter ionized calcium (iCa) are monitored.

Sample sites:

Arterial line, arterial (pre-filter) port, postfilter port (after postdilution and calcium compensation), effluent sample. All flow rates to be noted.

Study population:

Twelve patients admitted to intensive care, requiring continuous renal replacement therapy (CRRT) for AKI. Patients are preferably anuric and have achieved good metabolic control under CVVH before inclusion in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Critically ill patients requiring CRRT for AKI (RIFLE criteria)

• Written informed consent from the patient or legal representative

• No AV port reversal had taken place before inclusion in the study

• 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.

Exclusion Criteria:

• pre-existing chronic renal insufficiency requiring dialysis

• chronic immunosuppression

• liver cirrhosis Child-Pugh C

• severe or shock-related hepatitis

• Pregnancy

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• AV port reversal
Reversal of the AV port at 1h Reversal of the AV port to start position at 7h

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in citrate concentration in circuit after AV port reversal		8 hours
Primary	change in post-filter ionised Ca after AV port reversal		8 hours
Primary	change in clearance after AV port reversal		8 hours