Trial Outcomes & Findings for Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children (NCT NCT00370149)
NCT ID: NCT00370149
Last Updated: 2016-02-24
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
326 participants
Primary outcome timeframe
Participants were followed for the duration of the hospital stay, an average of 6 days.
Results posted on
2016-02-24
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
161
|
|
Overall Study
COMPLETED
|
146
|
142
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Physician Decision
|
16
|
16
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Catheter inserted in wrong vessel-
|
2
|
1
|
|
Overall Study
Pre-existing infection
|
0
|
1
|
|
Overall Study
Antibiotic coated dressing placed
|
0
|
1
|
Baseline Characteristics
Study of Catheter-related Infections Using Antibiotic-coated Versus Conventional Catheters in Children
Baseline characteristics by cohort
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=165 Participants
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).
|
Conventional Non-impregnated Catheters (C/S)
n=161 Participants
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).
|
Total
n=326 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
165 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
326 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=5 Participants
|
161 participants
n=7 Participants
|
326 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=146 Participants
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 one of two 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), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
|
Conventional Non-impregnated Catheters (C/S)
n=142 Participants
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).
|
|---|---|---|
|
Incidence of Catheter-related Bloodstream Infections (CRBSI) Per 1000 Catheter Days
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 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.
A secondary outcome measure was episodes of clinical sepsis and/or infection with identified source other than the CVC.
Outcome measures
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=146 Participants
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 one of two 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), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
|
Conventional Non-impregnated Catheters (C/S)
n=142 Participants
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).
|
|---|---|---|
|
Episodes of Clinical Sepsis and/or Infection With Identified Source Other Than Catheter
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 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.
Patient Death during hospitalization.
Outcome measures
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=146 Participants
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 one of two 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), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
|
Conventional Non-impregnated Catheters (C/S)
n=142 Participants
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).
|
|---|---|---|
|
Death
|
0 participants
|
0 participants
|
Adverse Events
Antibiotic Impregnated Catheters (M/R)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Conventional Non-impregnated Catheters (C/S)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=146 participants at risk
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.
|
Conventional Non-impregnated Catheters (C/S)
n=142 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Electromechanical Disassociation resulting in death
|
0.68%
1/146 • Number of events 1 • 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.
|
0.00%
0/142 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure and Chronic lung disease
|
0.00%
0/146 • 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.
|
0.70%
1/142 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Antibiotic Impregnated Catheters (M/R)
n=146 participants at risk
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.
|
Conventional Non-impregnated Catheters (C/S)
n=142 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Other Catheter related Complications
|
4.8%
7/146 • Number of events 7 • 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.
|
7.0%
10/142 • Number of events 10 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place