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Arterial Catheter to Monitor Glycemia (CAT-GLIC)

Primary Purpose

Critical Illness, Hyperglycemia

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Manual and automated washing of the peripherical lines
Automated washing of the peripherical lines
Sponsored by
Consorci Hospitalari de Vic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit

Eligibility Criteria

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

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

Sites / Locations

  • Vic Hospital Consortium - Consorci Hospitalari de VicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual and automated washing of the line

Automated washing of the line

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bacteremia episode originated from arterial catheter
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
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
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
Diagnosed by the means of Doppler ultrasonography
Ischemia or thrombosis of radial artery
Diagnosed by the means of Doppler ultrasonography
Arterial catheter obstruction
Blood sample obtention from arterial catheter is unavailable.
Glycose blood levels

Full Information

First Posted
August 4, 2010
Last Updated
August 5, 2010
Sponsor
Consorci Hospitalari de Vic
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1. Study Identification

Unique Protocol Identification Number
NCT01176279
Brief Title
Arterial Catheter to Monitor Glycemia
Acronym
CAT-GLIC
Official Title
Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Consorci Hospitalari de Vic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hyperglycemia
Keywords
Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual and automated washing of the line
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Automated washing of the line
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual and automated washing of the peripherical lines
Intervention Description
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 ™.
Intervention Type
Procedure
Intervention Name(s)
Automated washing of the peripherical lines
Intervention Description
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 ™.
Primary Outcome Measure Information:
Title
Bacteremia episode originated from arterial catheter
Description
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.
Time Frame
At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Secondary Outcome Measure Information:
Title
Local infection at cutaneous point of arterial catheter insertion
Description
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.
Time Frame
At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Title
Catheter colonization
Description
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.
Time Frame
At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Title
Radial artery pseudo-aneurysm
Description
Diagnosed by the means of Doppler ultrasonography
Time Frame
Between 48 and 96 hours after catheter's withdrawal
Title
Ischemia or thrombosis of radial artery
Description
Diagnosed by the means of Doppler ultrasonography
Time Frame
Between 48 and 96 hours after catheter's withdrawal
Title
Arterial catheter obstruction
Description
Blood sample obtention from arterial catheter is unavailable.
Time Frame
From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason
Title
Glycose blood levels
Time Frame
During the two days of catheter manipulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pere Roura-Poch, MD
Phone
+34.937.02.77.13
Email
proura@chv.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Raurell-Torredà
Organizational Affiliation
Vic Hospital Consortium - Consorci Hospitalari de Vic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vic Hospital Consortium - Consorci Hospitalari de Vic
City
Vic
State/Province
Catalonia
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa-Maria Catalan-Ibars, MD
First Name & Middle Initial & Last Name & Degree
Cesar Del-Llano
First Name & Middle Initial & Last Name & Degree
Dolors Almirall-Solsona

12. IPD Sharing Statement

Citations:
PubMed Identifier
11794168
Citation
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
Results Reference
background
PubMed Identifier
15565362
Citation
Kulkarni A, Saxena M, Price G, O'Leary MJ, Jacques T, Myburgh JA. Analysis of blood glucose measurements using capillary and arterial blood samples in intensive care patients. Intensive Care Med. 2005 Jan;31(1):142-5. doi: 10.1007/s00134-004-2500-5. Epub 2004 Nov 23.
Results Reference
background
PubMed Identifier
19318384
Citation
NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
Results Reference
background
PubMed Identifier
17595363
Citation
Lacara T, Domagtoy C, Lickliter D, Quattrocchi K, Snipes L, Kuszaj J, Prasnikar M. Comparison of point-of-care and laboratory glucose analysis in critically ill patients. Am J Crit Care. 2007 Jul;16(4):336-46; quiz 347.
Results Reference
background
PubMed Identifier
12233868
Citation
O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2002 Aug 9;51(RR-10):1-29.
Results Reference
background
PubMed Identifier
8674328
Citation
Peruzzi WT, Noskin GA, Moen SG, Yungbluth M, Lichtenthal P, Shapiro BA. Microbial contamination of blood conservation devices during routine use in the critical care setting: results of a prospective, randomized trial. Crit Care Med. 1996 Jul;24(7):1157-62. doi: 10.1097/00003246-199607000-00015.
Results Reference
result
Links:
URL
http://www.chv.cat
Description
Arterial Catheter to Monitor Glycemia

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