Clinical trial NCT01176279: Arterial Catheter to Monitor Glycemia
Official title: Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Critical Illness
Hyperglycemia
Keywords: Critical illness
Hyperglycemia
Catheters, Indwelling
Intensive care unit
Lead sponsor: Consorci Hospitalari de Vic
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Bacteremia episode originated from arterial catheter
timeFrame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Secondary outcomes:
measure: Local infection at cutaneous point of arterial catheter insertion
timeFrame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
measure: Catheter colonization
timeFrame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
measure: Radial artery pseudo-aneurysm
timeFrame: Between 48 and 96 hours after catheter's withdrawal
measure: Ischemia or thrombosis of radial artery
timeFrame: Between 48 and 96 hours after catheter's withdrawal
measure: Arterial catheter obstruction
timeFrame: From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason
measure: Glycose blood levels
timeFrame: During the two days of catheter manipulation
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Vic Hospital Consortium - Consorci Hospitalari de Vic
state: Catalonia
Study officials:
affiliation: Vic Hospital Consortium - Consorci Hospitalari de Vic
name: Marta Raurell-Torredà
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.