Critical IllnessPhase 4CAT-GLICNCT01176279

Arterial Catheter to Monitor Glycemia

A Phase 4 study testing Manual and automated washing of the peripherical lines and Automated washing of the peripherical lines in people with Critical Illness and Hyperglycemia, run by Consorci Hospitalari de Vic at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness, Hyperglycemia
What is being tested?: Manual and automated washing of the peripherical lines and Automated washing of the peripherical lines
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteSpain
Study dates: Apr 2008to Dec 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pere Roura-Poch, MD contact

+34.937.02.77.13

proura@chv.cat

Spain1 site, 1 recruiting

Vic Hospital Consortium - Consorci Hospitalari de Vic
Vic, Catalonia, 08243
Rosa-Maria Catalan-Ibars, MD
Cesar Del-Llano
Recruiting

Other trials in Spain

About this study

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

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
Being tested: Manual and automated washing of the peripherical lines, Automated washing of the peripherical lines
Keywords: Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit
Medical subject headings: Critical Illness, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual and automated washing of the peripherical linesProcedure or surgery
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 linesProcedure or surgery
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 ™.

Study groups in NCT01176279
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Automated washing of the peripherical lines

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
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.
Measured: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Radial artery pseudo-aneurysm
Diagnosed by the means of Doppler ultrasonography
Measured: Between 48 and 96 hours after catheter's withdrawal
Ischemia or thrombosis of radial artery
Diagnosed by the means of Doppler ultrasonography
Measured: Between 48 and 96 hours after catheter's withdrawal
Arterial catheter obstruction
Blood sample obtention from arterial catheter is unavailable.
Measured: From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason
Glycose blood levels
Measured: During the two days of catheter manipulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Dec 2011

First posted6 Aug 2010 (estimated)
Study startApr 2008
Primary completionJul 2011 (estimated)
Study completionDec 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Critical IllnessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01176279
Sponsor's protocol ID: CGLIC-2007-03
Acronym: CAT-GLIC
Status last verified: Jul 2010
First submitted: 4 Aug 2010
Last updated: 6 Aug 2010
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 11794168
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.
PubMed 15565362
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.
PubMed 19318384
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.
PubMed 17595363
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.
PubMed 12233868
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.
PubMed 8674328

Want to know more?

Pere Roura-Poch, MD

+34.937.02.77.13

proura@chv.cat

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised Clinical Trial to Evaluate the Obtention of Blood Samples Through an Arterial Catheter to Monitor Glycose Levels
ClinicalTrials.gov ID: NCT01176279
Acronym / sponsor ID: CAT-GLIC / CGLIC-2007-03
Conditions: Critical Illness, Hyperglycemia
Keywords: Critical illness, Hyperglycemia, Catheters, Indwelling, Intensive care unit
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Consorci Hospitalari de VicUniversity, hospital or other
Study start: Apr 2008
Primary completion: Jul 2011 (estimated)
Study completion: Dec 2011 (estimated)
First posted: 6 Aug 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Manual and automated washing of the line	Active comparator	Procedure: Manual and automated washing of the peripherical linesPlace 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.
Automated washing of the line	Experimental	Procedure: Automated washing of the peripherical linesPlace 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Manual and automated washing of the peripherical linesThe 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 ™.	Procedure or surgery	Manual and automated washing of the line
Automated washing of the peripherical linesThe 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 ™.	Procedure or surgery	Automated washing of the line

Primary outcome

Bacteremia episode originated from arterial catheter
Time frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
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.

6 secondary outcomes

Local infection at cutaneous point of arterial catheter insertion
Time frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Catheter colonization
Time frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)
Radial artery pseudo-aneurysm
Time frame: Between 48 and 96 hours after catheter's withdrawal
Ischemia or thrombosis of radial artery
Time frame: Between 48 and 96 hours after catheter's withdrawal
Arterial catheter obstruction
Time frame: From the date of arterial catheter insertion to withdrawal at seventh day or at any moment for any clinical reason
Glycose blood levels
Time frame: During the two days of catheter manipulation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
Background: PubMed 11794168van 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.
Background: PubMed 15565362Kulkarni 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.
Background: PubMed 19318384NICE-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.
Background: PubMed 17595363Lacara 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.
Background: PubMed 12233868O'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 publication: PubMed 8674328Peruzzi 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.
Arterial Catheter to Monitor GlycemiaLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pere Roura-Poch, MD contact

+34.937.02.77.13

proura@chv.cat

Marta Raurell-Torredà principal investigator

Vic Hospital Consortium - Consorci Hospitalari de Vic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pere Roura-Poch, MD (+34.937.02.77.13, proura@chv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bacteremia episode originated from arterial catheter (time frame: At catheter's withdrawal (at seventh day of insertion or at any moment for any clinical reason)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01176279, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2010.