Study Results
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Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2008-04-30
2011-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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 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.
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 ™.
Interventions
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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 ™.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Consorci Hospitalari de Vic
OTHER
Responsible Party
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Vic Hospital Consortium - Consorci Hospitalari de Vic
Principal Investigators
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Marta Raurell-Torredà
Role: PRINCIPAL_INVESTIGATOR
Vic Hospital Consortium - Consorci Hospitalari de Vic
Locations
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Vic Hospital Consortium - Consorci Hospitalari de Vic
Vic, Catalonia, Spain
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Arterial Catheter to Monitor Glycemia
Other Identifiers
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CGLIC-2007-03
Identifier Type: -
Identifier Source: org_study_id
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