Infection Prevention
Conditions
Brief summary
The primary purpose of the study is to determine if a therapeutic difference exists between central venous catheters impregnated with minocycline and rifampin and conventional catheters not impregnated with antibiotics when used in children at high risk for bloodstream infections (CABSI) after cardiac surgery.
Detailed description
The standard central venous catheter (CVC) is now commonly used for infants, children, and adults. The antibiotic-coated CVC is a newer CVC gaining popularity for use in adults. The Food and Drug Administration (FDA) and the Center for Disease Control (CDC) support use of the antibiotic-coated CVC for adult patients. But the FDA and CDC have not yet endorsed use of the antibiotic-coated CVC for infants and children due to lack of research on this CVC in infants and children.
Interventions
DEVICEAntibiotic-impregnated Catheters (M/R)
Patients randomized to this arm will have the antibiotic-impregnated catheters inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
DEVICENon-impregnated Catheters (C/S)
Patients randomized to this arm will have the central venous catheter inserted intra-operatively. The catheters are sized to accommodate children in different size ranges.
Sponsors
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age \< 18 years * Cardiovascular surgery patient with a case complexity warranting CVC placement longer than 3 days * Study devices of appropriate size for patient use without modification * Informed consent obtained prior to patient entering the operating room
Exclusion criteria
* Age ≥ 18 years * Drug allergy to minocycline, other tetracyclines, or rifampin * Ventricular assist device (VAD) therapy * Extracorporeal membrane oxygenation (ECMO) therapy * Patients undergoing cardiac transplant * Any active infection or being treated for bacteremia at the time of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days | Participants were followed for the duration of the hospital stay, an average of 6 days. | Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter | Participants were followed for the duration of hospital stay, an average of 6 days. | A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC. |
| Death | Participants were followed for the duration of the hospital stay, an average of 6 days. | Patient Death during hospitalization. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited and consented during pre-operative visits at Riley Hospital between September 2006 and May 2010. Study catheters were assigned a random identification number by Cook Critical Care, Bloomington, IN. The clinical and infection control teams were blinded to which arm a patient was assigned.
Pre-assignment details
Patients \<18 years of age who had cardiovascular surgery with a case complexity warranting a central venous catheter received either an antibiotic impregnated catheter or a conventional non-impregnated catheter on a randomized, blinded 1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Antibiotic Impregnated Catheters (M/R) Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). | 165 |
| Conventional Non-impregnated Catheters (C/S) Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC). | 161 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Antibiotic coated dressing placed | 0 | 1 |
| Overall Study | Catheter inserted in wrong vessel- | 2 | 1 |
| Overall Study | Physician Decision | 16 | 16 |
| Overall Study | Pre-existing infection | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Antibiotic Impregnated Catheters (M/R) | Conventional Non-impregnated Catheters (C/S) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 165 Participants | 161 Participants | 326 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 165 participants | 161 participants | 326 participants |
| Sex: Female, Male Female | 84 Participants | 84 Participants | 168 Participants |
| Sex: Female, Male Male | 81 Participants | 77 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 146 | 10 / 142 |
| serious Total, serious adverse events | 1 / 146 | 1 / 142 |
Outcome results
Primary
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
Rates of CRBSI defined as 1. micro-organism isolated from a blood culture; 2. Clinical manifestations of infection such as fever (≥38 C) and/or hypotension (defined according to age-related practice guidelines for systolic blood pressure); 3. No apparent source for the bloodstream infection except for the catheter.
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Population: The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antibiotic Impregnated Catheters (M/R) | Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days | 3 participants |
| Conventional Non-impregnated Catheters (C/S) | Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days | 3 participants |
Secondary
Death
Patient Death during hospitalization.
Time frame: Participants were followed for the duration of the hospital stay, an average of 6 days.
Population: The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antibiotic Impregnated Catheters (M/R) | Death | 0 participants |
| Conventional Non-impregnated Catheters (C/S) | Death | 0 participants |
Secondary
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
Time frame: Participants were followed for the duration of hospital stay, an average of 6 days.
Population: The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Antibiotic Impregnated Catheters (M/R) | Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter | 8 participants |
| Conventional Non-impregnated Catheters (C/S) | Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter | 4 participants |