Central Line-associated Bloodstream Infection (CLABSI)PRECiSENCT03282292
Central Venous Catheter Insertion Site and Colonization in Pediatric Cardiac Surgery
A study testing Internal jugular vein CVC insertion in people with Central Line-associated Bloodstream Infection (CLABSI) and Central Venous Catheter Associated Bloodstream Infection, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Internal jugular vein CVC insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2017to 12 Oct 2019
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Planned cardiac surgery Age <1 year Eligibility for both insertion sites (jugular and femoral) for CVC Availability of at least one out of the three chosen expert operators
Who cannot join
- Emergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6 months No expert operator availability Intensive Care unit before surgery Central venous catheter inside at the time of randomization
- Withdraw criteria (only for the first endpoint):
- Impossibility to placement catheter in the selected site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.
Read the detailed description
Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher risk of colonization and central-line associated bloodstream infection (CLABSI) than other sites (jugular or subclavian). In pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and CLABSI related to the insertion site. The experimental hypothesis of this randomized controlled trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization and CLABSI than the femoral site.
Methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC insertion will be performed by one out of three selected expert operators.
The primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection.
Secondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.
- Conditions
- Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result, Congenital Heart Disease, Newborn; Infection
- Being tested
- Internal jugular vein CVC insertion
- Medical subject headings
- Heart Defects, Congenital, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal jugular vein CVC insertionProcedure or surgery
Double lumen CVC insertion in the internal jugular vein
| Study group | Role | What they receive |
|---|---|---|
| Jugular | Experimental | CVC insertion in the left or right internal jugular vein Receives: Procedure: Internal jugular vein CVC insertion |
| Femoral | Active comparator | CVC insertion in the right or left femoral vein Receives: Procedure: Internal jugular vein CVC insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVC colonization
CVC positive culture after removal
Measured: 14 days
CRBSI
Positive CVC culture and blood stream infection for the same organism
Measured: 14 days
CLABSI
A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.
Measured: More than 48 hours
Secondary outcomes (2)
Mechanical complications
Defined as arterial puncture; hemothorax; pneumothorax
Measured: 1 day
Procedural difficulty
Defined by number of attempts; no guidewire progress
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start12 Sep 2017
- Primary completion12 Sep 2019
- Study completion12 Oct 2019
Why it stopped: Co-PI responsible for study procedures moved to another hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Central Line-associated Bloodstream Infection (CLABSI)Studies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
- Investigators
- Marco Ranucci, MD, Study director, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282292
- Sponsor's protocol ID
- PedCVC
- Acronym
- PRECiSE
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will be made available at reasonable request
Publications
Collignon P, Soni N, Pearson I, Sorrell T, Woods P. Sepsis associated with central vein catheters in critically ill patients. Intensive Care Med. 1988;14(3):227-31. doi: 10.1007/BF00717995.
PubMed 3379183Pearson ML. Guideline for prevention of intravascular device-related infections. Part I. Intravascular device-related infections: an overview. The Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996 Aug;24(4):262-77. doi: 10.1016/s0196-6553(96)90058-9. No abstract available.
PubMed 8870910de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
PubMed 15857534Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.
PubMed 17875082Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.
PubMed 12797890Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System. Crit Care Med. 1999 May;27(5):887-92. doi: 10.1097/00003246-199905000-00020.
PubMed 10362409Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.
PubMed 2921683He C, Vieira R, Marin JR. Utility of Ultrasound Guidance for Central Venous Access in Children. Pediatr Emerg Care. 2017 May;33(5):359-362. doi: 10.1097/PEC.0000000000001124.
PubMed 28471906Sanchez Sanchez A, Giron Vallejo O, Ruiz-Pruneda R, Fernandez Ibieta M, Reyes Rios PY, Villamil V, Martinez-Castano I, Rojas Ticona J, Gimenez Aleixandre MC, Ruiz Jimenez JI. [Use of ultrasound for placement of central venous catheters in pediatrics: results of a national survey]. Cir Pediatr. 2017 Jan 25;30(1):9-16. Spanish.
PubMed 28585784Silvetti S, Aloisio T, Cazzaniga A, Ranucci M. Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):329. doi: 10.1186/s13063-018-2717-1.
PubMed 29941012
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Catheter Insertion Site and Catheter Colonization and Bloodstream Infection in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03282292
- Acronym / sponsor ID
- PRECiSE / PedCVC
- Conditions
- Central Line-associated Bloodstream Infection (CLABSI), Central Venous Catheter Associated Bloodstream Infection, Heart; Surgery, Heart, Functional Disturbance as Result, Congenital Heart Disease, Newborn; Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Co-PI responsible for study procedures moved to another hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Oct 2019 (actual)
- First posted
- 13 Sep 2017 (actual)
- 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.
Randomized controlled trial comparing femoral vs internal jugular insertion site of central venous catheters (CVC) in newborns and infants undergoing cardiac surgery. The experimental hypothesis is that the jugular insertion site is superior to the femoral in terms of catheter colonization.
Detailed description
Background: in adult patients, the femoral site of insertion of CVC is notoriously at higher risk of colonization and central-line associated bloodstream infection (CLABSI) than other sites (jugular or subclavian). In pediatric patients, the femoral site is more commonly used than in adult patients, but there is no sound data on catheter colonization and CLABSI related to the insertion site. The experimental hypothesis of this randomized controlled trial (RCT) is that the jugular insertion site is less likely to induce catheter colonization and CLABSI than the femoral site.
Methods: 160 patients under 1 year and scheduled for cardiac surgery will be included in this RCT; patients will be randomly allocated to the jugular (J Group) or Femoral (F Group). CVC insertion will be performed by one out of three selected expert operators.
The primary endpoint is the catheter colonization based on identification of bacterial grow into the catheter at removal time; CLABSI and CRBSI rate based on the same bacterial identification into the catheter tip and in the blood culture performed in case of signs and symptoms of infection.
Secondary endpoints are mechanical complications defined as arterial puncture immediately identified during procedure, hemothorax and pneumothorax; and procedural difficulty during insertion defined as number of attempts, no guidewire progress, duration of the procedure (time from the completion of the sterile precaution barriers and the catheter fixation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Jugular | Experimental | Procedure: Internal jugular vein CVC insertionCVC insertion in the left or right internal jugular vein |
| Femoral | Active comparator | Procedure: Internal jugular vein CVC insertionCVC insertion in the right or left femoral vein |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Planned cardiac surgery Age <1 year Eligibility for both insertion sites (jugular and femoral) for CVC Availability of at least one out of the three chosen expert operators
Key exclusion criteria (3 listed)
- Emergency surgery Known vascular anatomic anomalies Previous cardiac surgery in the last 6 months No expert operator availability Intensive Care unit before surgery Central venous catheter inside at the time of randomization
- Impossibility to placement catheter in the selected site.
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 |
|---|---|---|
| Internal jugular vein CVC insertionDouble lumen CVC insertion in the internal jugular vein | Procedure or surgery | Femoral, Jugular |
Primary outcome
CVC colonization
Time frame: 14 days
CVC positive culture after removal
CRBSI
Time frame: 14 days
Positive CVC culture and blood stream infection for the same organism
CLABSI
Time frame: More than 48 hours
A laboratory-confirmed bloodstream infection where central line was in place for more than 48h.
2 secondary outcomes
Mechanical complications
Time frame: 1 day
Procedural difficulty
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 3379183Collignon P, Soni N, Pearson I, Sorrell T, Woods P. Sepsis associated with central vein catheters in critically ill patients. Intensive Care Med. 1988;14(3):227-31. doi: 10.1007/BF00717995.
- Results publication: PubMed 8870910Pearson ML. Guideline for prevention of intravascular device-related infections. Part I. Intravascular device-related infections: an overview. The Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1996 Aug;24(4):262-77. doi: 10.1016/s0196-6553(96)90058-9. No abstract available.
- Results publication: PubMed 15857534de Jonge RC, Polderman KH, Gemke RJ. Central venous catheter use in the pediatric patient: mechanical and infectious complications. Pediatr Crit Care Med. 2005 May;6(3):329-39. doi: 10.1097/01.PCC.0000161074.94315.0A.
- Results publication: PubMed 17875082Karapinar B, Cura A. Complications of central venous catheterization in critically ill children. Pediatr Int. 2007 Oct;49(5):593-9. doi: 10.1111/j.1442-200X.2007.02407.x.
- Results publication: PubMed 12797890Casado-Flores J, Barja J, Martino R, Serrano A, Valdivielso A. Complications of central venous catheterization in critically ill children. Pediatr Crit Care Med. 2001 Jan;2(1):57-62. doi: 10.1097/00130478-200101000-00012.
- Results publication: PubMed 10362409Richards MJ, Edwards JR, Culver DH, Gaynes RP. Nosocomial infections in medical intensive care units in the United States. National Nosocomial Infections Surveillance System. Crit Care Med. 1999 May;27(5):887-92. doi: 10.1097/00003246-199905000-00020.
- Results publication: PubMed 2921683Stenzel JP, Green TP, Fuhrman BP, Carlson PE, Marchessault RP. Percutaneous femoral venous catheterizations: a prospective study of complications. J Pediatr. 1989 Mar;114(3):411-5. doi: 10.1016/s0022-3476(89)80559-1.
- Results publication: PubMed 28471906He C, Vieira R, Marin JR. Utility of Ultrasound Guidance for Central Venous Access in Children. Pediatr Emerg Care. 2017 May;33(5):359-362. doi: 10.1097/PEC.0000000000001124.
- Results publication: PubMed 28585784Sanchez Sanchez A, Giron Vallejo O, Ruiz-Pruneda R, Fernandez Ibieta M, Reyes Rios PY, Villamil V, Martinez-Castano I, Rojas Ticona J, Gimenez Aleixandre MC, Ruiz Jimenez JI. [Use of ultrasound for placement of central venous catheters in pediatrics: results of a national survey]. Cir Pediatr. 2017 Jan 25;30(1):9-16. Spanish.
- Derived from this study: PubMed 29941012Silvetti S, Aloisio T, Cazzaniga A, Ranucci M. Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial. Trials. 2018 Jun 25;19(1):329. doi: 10.1186/s13063-018-2717-1.
- Individual participant dataSharing planned: Yes. The dataset will be made available at reasonable request
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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.
Marco Ranucci, MD study director
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal jugular vein CVC insertion in people with Central Line-associated Bloodstream Infection (CLABSI) and Central Venous Catheter Associated Bloodstream Infection, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 1 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. 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 Italy. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CVC colonization (time frame: 14 days). The study lists 3 primary outcomes in all. 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 NCT03282292, which also lists 10 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 18 Nov 2023.