Not provided
Not provided
Not provided
Not provided
Not provided
Blinded interim analysis resulted in early termination of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic-impregnated Catheters (M/R) | Active Comparator | Interventions is insertion intra-operatively of catheters impregnated with minocycline and rifampin to determine if their is a therapeutic difference between this catheter and the placebo (non-impregnated) catheter. The catheters are sized to accommodate children in different size ranges: Cook Inc. Double Lumen 4 Fr., 8 cm long, (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). |
|
| Non-impregnated Catheter (C/S) | Placebo Comparator | Intervention is insertion intra-operatively of conventional, non-impregnated catheters. There are 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), and 5 Fr., 12 cm long (C-UDLM-501J-RSC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic-impregnated Catheters (M/R) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were followed for the duration of the hospital stay, an average of 6 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were followed for the duration of hospital stay, an average of 6 days. |
| Death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elaine G. Cox, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26619445 | Result | Cox EG, Knoderer CA, Jennings A, Brown JW, Rodefeld MD, Walker SG, Turrentine MW. A Randomized, Controlled Trial of Catheter-Related Infectious Event Rates Using Antibiotic-Impregnated Catheters Versus Conventional Catheters in Pediatric Cardiovascular Surgery Patients. J Pediatric Infect Dis Soc. 2013 Mar;2(1):67-70. doi: 10.1093/jpids/pis066. Epub 2012 Jul 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotic Impregnated Catheters (M/R) | Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM). |
| FG001 | Conventional Non-impregnated Catheters (C/S) | Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to the treatment assigned at randomization. | Posted | Number | participants | Participants were followed for the duration of the hospital stay, an average of 6 days. |
|
Adverse device effects and adverse events were collected during the participants' hospitalizations which ranged from 5 - 10 days.
Daily evaluation through hospital discharge included fever, blood pressure, white blood cell count, platelet count, glucose, arrhythmia, urine output, or additional antibiotic administration. Any catheter related complication, including pneumothorax, thrombosis,occlusion, displacement, leakage, fracture, or fragmentation was recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotic Impregnated Catheters (M/R) | Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electromechanical Disassociation resulting in death | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other Catheter related Complications | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
A blinded interim analysis by an independent Data Safety Monitoring Board resulted in early termination of the study: of 288 evaluable patients, the rates of CRBSI and line-related complications were similar between the 2 groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine G Cox, MD | Riley Hospital for Children | 317-944-7260 | elmcox@iu.edu |
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-impregnated Catheters (C/S) | Device | 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. |
|
Patient Death during hospitalization. |
| Participants were followed for the duration of the hospital stay, an average of 6 days. |
| Catheter inserted in wrong vessel- |
|
| Pre-existing infection |
|
| Antibiotic coated dressing placed |
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 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). |
|
|
| 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. | The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization. | Posted | Number | participants | Participants were followed for the duration of hospital stay, an average of 6 days. |
|
|
|
| Secondary | Death | Patient Death during hospitalization. | The intention-to-treat population consisted of all randomized participants with valid informed consent. Participants were analyzed according to treatment assigned at randomization. | Posted | Number | participants | Participants were followed for the duration of the hospital stay, an average of 6 days. |
|
|
|
| 1 |
| 146 |
| 7 |
| 146 |
| EG001 | Conventional Non-impregnated Catheters (C/S) | Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay | 1 | 142 | 10 | 142 |
| Respiratory Failure and Chronic lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided