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Completed

NCT Number: NCT02600416

The CIRE Study (CItrate REcirculation Study)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV port reversal

Other

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

Primary outcomes

  1. change in citrate concentration in circuit after AV port reversal

    Time frame: 8 hours

  2. change in post-filter ionised Ca after AV port reversal

    Time frame: 8 hours

  3. change in clearance after AV port reversal

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

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

Acronym: CIRE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2015
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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