Acute Kidney InjuryCIRENCT02600416
The CIRE Study (CItrate REcirculation Study)
A study testing AV port reversal in people with Acute Kidney Injury, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AV port reversal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2015to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pre-existing chronic renal insufficiency requiring dialysis
- chronic immunosuppression
- liver cirrhosis Child-Pugh C
- severe or shock-related hepatitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of AV Port Reversal in Citrate CVVH - 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- AV port reversal
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV port reversalOther
Reversal of the AV port at 1h Reversal of the AV port to start position at 7h
| Study group | Role | What they receive |
|---|---|---|
| AV port reversal | Other | Patients undergoing citrate CVVH. Receives: Other: AV port reversal |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in citrate concentration in circuit after AV port reversal
Measured: 8 hours
change in post-filter ionised Ca after AV port reversal
Measured: 8 hours
change in clearance after AV port reversal
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willem Boer, Ziekenhuis Oost-Limburg
- Investigators
- Willem Boer, MD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600416
- Sponsor's protocol ID
- CIRE study
- Acronym
- CIRE
- Status last verified
- Mar 2018
- First submitted
- 15 Oct 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of AV Port Reversal in Citrate CVVH - The CIRE Study (CItrate REcirculation Study)
- ClinicalTrials.gov ID
- NCT02600416
- Acronym / sponsor ID
- CIRE / CIRE study
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AV port reversal | Other | Other: AV port reversalPatients undergoing citrate CVVH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- pre-existing chronic renal insufficiency requiring dialysis
- chronic immunosuppression
- liver cirrhosis Child-Pugh C
- severe or shock-related hepatitis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV port reversalReversal of the AV port at 1h Reversal of the AV port to start position at 7h | Other | AV port reversal |
Primary outcome
change in citrate concentration in circuit after AV port reversal
Time frame: 8 hours
change in post-filter ionised Ca after AV port reversal
Time frame: 8 hours
change in clearance after AV port reversal
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem Boer, MD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AV port reversal in people with Acute Kidney Injury, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in citrate concentration in circuit after AV port reversal (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.