Arterial Catheter to Monitor Glycemia (CAT-GLIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Consorci Hospitalari de Vic.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier:
NCT01176279
First received: August 4, 2010
Last updated: August 5, 2010
Last verified: July 2010
  Purpose

The technique of blood samples extraction from the radial artery through an arterial catheter with a 3-way stopcock and automated washing with valve of fast flow is better than the one carried out through a fixed reusable arterial blood sample syringe and its manual washing because it shows a minor incidence of the complications originated from technical manipulation as infection, pseudo-aneurysm, ischemia or thrombosis of radial artery or obstruction of the catheter.

The purpose of this study is to evaluate the efficacy, in terms of adverse effects, of blood samples obtention using an arterial catheter with needless connector closed system or an arterial catheter with an arterial blood sample syringe.

Also a second purpose is to compare once a day (at the same time) the values of glycose blood levels between bedside glucometer determination of arterial catheter extraction and capillar puncture, and lab determination of glycose from venous puncture, in order to determinate fluctuation in glycose levels due to peripherical hypoperfusion or to vasoactive drugs received by these in-intensive care unit patients.


Condition Intervention Phase
Critical Illness
Hyperglycemia
Procedure: Manual and automated washing of the peripherical lines
Procedure: Automated washing of the peripherical lines
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels

Resource links provided by NLM:


Further study details as provided by Consorci Hospitalari de Vic:

Primary Outcome Measures:
  • Bacteremia episode originated from arterial catheter [ Time Frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) ] [ Designated as safety issue: Yes ]
    Catheter-related bloodstream infection as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.


Secondary Outcome Measures:
  • Local infection at cutaneous point of arterial catheter insertion [ Time Frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) ] [ Designated as safety issue: Yes ]
    Exit site infection as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.

  • Catheter colonization [ Time Frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason) ] [ Designated as safety issue: Yes ]
    Localized catheter colonization as defined in Appendix A of "Guidelines for the Prevention of Intravascular Catheter-Related Infections". Centers for disease control and prevention (CDC) 2002 August 9: 51(RR10); 27.

  • Radial artery pseudo-aneurysm [ Time Frame: Between 48 and 96 hours after catheter's withdrawal ] [ Designated as safety issue: Yes ]
    Diagnosed by the means of Doppler ultrasonography

  • Ischemia or thrombosis of radial artery [ Time Frame: Between 48 and 96 hours after catheter's withdrawal ] [ Designated as safety issue: Yes ]
    Diagnosed by the means of Doppler ultrasonography

  • Arterial catheter obstruction [ Time Frame: From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason ] [ Designated as safety issue: Yes ]
    Blood sample obtention from arterial catheter is unavailable.

  • Glycose blood levels [ Time Frame: During the two days of catheter manipulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Manual and automated washing of the line
Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of TM BD DTXPlus ™), put the needless connector included in the kit to make the extractions of blood. Connect an arterial blood sampling syringe on the proximal 3-way stopcock key. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.
Procedure: Manual and automated washing of the peripherical lines

The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours.

Obtain 2cc of blood using the arterial blood sampling syringe connected to the proximal key. This volume of rejection is reserved in the syringe itself.

In accordance with the current protocol of disinfection, the needless connector inserted on the distal key will be disinfected. With a disposable sterile syringe the needless connector is punctured and a minimum blood amount is obtained for the determination of the glycaemia.

Once the sample has been obtained, the rejection volume reserved is returned to the bloodstream. This arterial blood sampling syringe is cleaned aspirating serum manually in order to wash the line.

Additional line washing is made through the fast flow valve of the system BD DTXPlus ™.

Experimental: Automated washing of the line
Place in the radial artery the system of invasive monitoring of the blood pressure (BD DTXPlus ™). Insert in line a second 3-way stopcock above the one that has the BD DTXPlus ™; this second 3-way stopcock will be called proximal key. On the distal 3-way stopcock key (the one of BD DTXPlus™), put the needless connector included in the kit to make the extractions of blood. On the proximal 3-way stopcock key put a second identical needless connector: in the intervention group the two 3-way stopcock keys have, each one, a needless connector. With the assembled system, it is necessary to print a curve of invasive determination of the blood pressure.
Procedure: Automated washing of the peripherical lines

The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours.

In accordance with the current protocol of disinfection, the two needless connectors inserted on the two 3-way stopcock keys will be disinfected.

With a disposable sterile syringe the needless connector on proximal 3-way stopcock is punctured and 2cc of blood are aspirated. This volume of rejection is reserved in the syringe itself and it is not disconnected.

With a second disposable sterile syringe the needless connector on distal 3-way stopcock key is punctured and a minimum blood amount is obtained for the determination of the glycaemia.

Once the sample has been obtained, the rejection volume reserved in the disposable syringe connected to the proximal 3-way stopcock is returned to the bloodstream.

Line washing will be made through the fast flow valve of the system BD DTXPlus ™.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admission in intensive care unit
  • Insertion of a radial artery catheter for the invasive monitoring of haemodynamic pressure for a maximum of 5 days
  • Need of insulin therapy by an intravenous continuous perfusion

Exclusion Criteria:

  • Patients who do not accept to participate (or their relatives do not accept)
  • Patients with a medical limitation of effort therapy
  • Patients with FloTrac sensor from Edwards Lifesciences which does not allow to add a supplementary 3-way stopcock
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176279

Contacts
Contact: Pere Roura-Poch, MD +34.937.02.77.13 proura@chv.cat

Locations
Spain
Vic Hospital Consortium - Consorci Hospitalari de Vic Recruiting
Vic, Catalonia, Spain, 08243
Sub-Investigator: Rosa-Maria Catalan-Ibars, MD         
Sub-Investigator: Cesar Del-Llano         
Sub-Investigator: Dolors Almirall-Solsona         
Sponsors and Collaborators
Consorci Hospitalari de Vic
Investigators
Principal Investigator: Marta Raurell-Torredà Vic Hospital Consortium - Consorci Hospitalari de Vic
  More Information

Additional Information:
Publications:

Responsible Party: Mrs. Marta Raurell-Torredà, Vic Hospital Consortium - Consorci Hospitalari de Vic
ClinicalTrials.gov Identifier: NCT01176279     History of Changes
Other Study ID Numbers: CGLIC-2007-03
Study First Received: August 4, 2010
Last Updated: August 5, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Consorci Hospitalari de Vic:
Critical illness
Hyperglycemia
Catheters, Indwelling
Intensive care unit

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014