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Trial record 13 of 109 for:    CALCIUM CATION

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

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE November 9, 2015
Last Update Posted Date March 30, 2018
Study Start Date  ICMJE December 2015
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02600416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CIRE Study (CItrate REcirculation Study)
Official Title  ICMJE Effects of AV Port Reversal in Citrate CVVH - The CIRE Study (CItrate REcirculation Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE Other: AV port reversal
Reversal of the AV port at 1h Reversal of the AV port to start position at 7h
Study Arms  ICMJE AV port reversal
Patients undergoing citrate CVVH.
Intervention: Other: AV port reversal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2015)
12
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02600416
Other Study ID Numbers  ICMJE CIRE study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Willem Boer, Ziekenhuis Oost-Limburg
Study Sponsor  ICMJE Ziekenhuis Oost-Limburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Willem Boer, MD Ziekenhuis Oost-Limburg
PRS Account Ziekenhuis Oost-Limburg
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP