Arterial Catheter to Monitor Glycemia

NCT01176279 | Unknown Phase 4 DMC

• 1 other identifier: CGLIC-2007-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Hyperglycemia

Keywords

Critical illness; Hyperglycemia; Catheters, Indwelling; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Local infection at cutaneous point of arterial catheter insertion

  At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)

• Catheter colonization

  At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)

• Radial artery pseudo-aneurysm

  Between 48 and 96 hours after catheter's withdrawal

• Ischemia or thrombosis of radial artery

  Between 48 and 96 hours after catheter's withdrawal

• Arterial catheter obstruction

  From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason

Study Arms (2)

Manual and automated washing of the line

ACTIVE COMPARATOR

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

Automated washing of the line

EXPERIMENTAL

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

Interventions

Manual and automated washing of the peripherical lines PROCEDURE

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 ™.

Manual and automated washing of the line

Automated washing of the peripherical lines PROCEDURE

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 ™.

Automated washing of the line

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci Hospitalari de Vic: lead

Study Sites (1)

Vic Hospital Consortium - Consorci Hospitalari de Vic

Vic, Catalonia, 08243, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 11794168 BACKGROUND

• 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.

  PMID: 15565362 BACKGROUND

• 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.

  PMID: 19318384 BACKGROUND

• 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.

  PMID: 17595363 BACKGROUND

• 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.

  PMID: 12233868 BACKGROUND

• 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.

  PMID: 8674328 RESULT

Related Links

• Arterial Catheter to Monitor Glycemia

MeSH Terms

Conditions

Critical Illness; Hyperglycemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marta Raurell-Torredà

  Vic Hospital Consortium - Consorci Hospitalari de Vic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pere Roura-Poch, MD

CONTACT

+34.937.02.77.13; proura@chv.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 6, 2010

Record last verified: 2010-07

Locations

ES (1)