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The CIRE Study (CItrate REcirculation Study) (CIRE)

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ClinicalTrials.gov Identifier: NCT02600416
Recruitment Status : Completed
First Posted : November 9, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Willem Boer, Ziekenhuis Oost-Limburg

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: AV port reversal Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of AV Port Reversal in Citrate CVVH - The CIRE Study (CItrate REcirculation Study)
Study Start Date : December 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AV port reversal
Patients undergoing citrate CVVH.
Other: AV port reversal
Reversal of the AV port at 1h Reversal of the AV port to start position at 7h




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600416


Locations
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Belgium
Ziekenhuis Oost Limburg
Genk, Limburg, Belgium, 3600
Sponsors and Collaborators
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: Willem Boer, MD Ziekenhuis Oost-Limburg

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Responsible Party: Willem Boer, MD, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT02600416     History of Changes
Other Study ID Numbers: CIRE study
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action