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The CIRE Study (CItrate REcirculation Study) (CIRE)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
AV port reversal
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost Limburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AV port reversal

Arm Description

Patients undergoing citrate CVVH.

Outcomes

Primary Outcome Measures

change in citrate concentration in circuit after AV port reversal
change in post-filter ionised Ca after AV port reversal
change in clearance after AV port reversal

Secondary Outcome Measures

Full Information

First Posted
October 15, 2015
Last Updated
March 28, 2018
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT02600416
Brief Title
The CIRE Study (CItrate REcirculation Study)
Acronym
CIRE
Official Title
Effects of AV Port Reversal in Citrate CVVH - The CIRE Study (CItrate REcirculation Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
September 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV port reversal
Arm Type
Other
Arm Description
Patients undergoing citrate CVVH.
Intervention Type
Other
Intervention Name(s)
AV port reversal
Intervention Description
Reversal of the AV port at 1h Reversal of the AV port to start position at 7h
Primary Outcome Measure Information:
Title
change in citrate concentration in circuit after AV port reversal
Time Frame
8 hours
Title
change in post-filter ionised Ca after AV port reversal
Time Frame
8 hours
Title
change in clearance after AV port reversal
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem Boer, MD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

The CIRE Study (CItrate REcirculation Study)

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