Arterial Catheter to Monitor Glycemia

Critical Illness Clinical Trial

— CAT-GLIC  

Official title:

Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01176279
• Other study ID #: CGLIC-2007-03
• Status: Recruiting
• Phase: Phase 4
• First received: August 4, 2010
• Last updated: August 5, 2010
• Start date: April 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2010
• Source: Consorci Hospitalari de Vic
• Contact: Pere Roura-Poch, MD
• Phone: +34.937.02.77.13
• Email: proura[@]chv.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia

Intervention

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 ™.
• 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 ™.

Locations

Country	Name	City	State
Spain	Vic Hospital Consortium - Consorci Hospitalari de Vic	Vic	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Hospitalari de Vic

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Epub 2004 Nov 23. — View 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. — View 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, Hébert 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. — View 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. — View 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):1157-6 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Yes
Secondary	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.	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Yes
Secondary	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.	At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)	Yes
Secondary	Radial artery pseudo-aneurysm	Diagnosed by the means of Doppler ultrasonography	Between 48 and 96 hours after catheter's withdrawal	Yes
Secondary	Ischemia or thrombosis of radial artery	Diagnosed by the means of Doppler ultrasonography	Between 48 and 96 hours after catheter's withdrawal	Yes
Secondary	Arterial catheter obstruction	Blood sample obtention from arterial catheter is unavailable.	From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason	Yes
Secondary	Glycose blood levels		During the two days of catheter manipulation	No

External Links

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