Catheter-related Bloodstream Infection (CRBSI) Nos, Bloodstream Infection Due to Central Venous Catheter, Bloodstream Infection Due to Hickman Catheter
Conditions
Keywords
Home Parenteral Nutrition, Infection Prevention, CRBSI, Ethanol Lock Therapy
Brief summary
This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.
Detailed description
Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.
Interventions
DRUGEthanol
Prophylactic ELT will be administered at the time when the HPN is not being infused.
DRUGHeparin Lock
3 mL of 100 U/ml heparin
DRUGNormal Saline
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Newly started on Home parenteral Nutrition and anticipated duration \>3 months. * Not previously on Home Parenteral Nutrition. * Providing consent. * Patients with non-medicare insurance. * Patients with medicare insurance and a supplementary insurance. * Patients with single lumen Hickman® catheters. * No known alcohol addiction.
Exclusion criteria
* Failure to provide consent * Patients with medicare insurance and no other supplemental private insurance * Patients with a catheter type other than a single lumen Hickman® * Patients who are on HPN for less than three months * Pregnant patients * Patients who have previous proven addiction and dependence to alcohol. * Patients lacking capacity to provide consent * Patients who are not be managed by HPN team at investigator's institution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Catheter-Related Blood Stream Infections | 1 year | The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and \>1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter. |
Countries
United States
Participant flow
Recruitment details
This clinical trial was carried out from July 2014 to April 2016 at the Mayo Clinic in Rochester, Minnesota.
Pre-assignment details
39 subjects were consented, but one subject was excluded after enrollment due to incompatibility with ongoing treatment (ongoing metronidazole use).
Participants by arm
| Arm | Count |
|---|---|
| Ethanol Lock and Normal Saline All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush. | 18 |
| Heparin and Normal Saline All patients randomized to this group will receive Heparin lock (3 mL of 100 U/ml heparin) + saline infusion (current standard of care). | 20 |
| Total | 38 |
Baseline characteristics
| Characteristic | Ethanol Lock and Normal Saline | Heparin and Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 16 | 52 years STANDARD_DEVIATION 16 | 51 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 18 Participants | 20 Participants | 38 Participants |
| Sex: Female, Male Female | 12 Participants | 14 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 20 |
| other Total, other adverse events | 4 / 18 | 1 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
Number of Catheter-Related Blood Stream Infections
The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and \>1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ethanol Lock and Normal Saline | Number of Catheter-Related Blood Stream Infections | 4 infections |
| Heparin and Normal Saline | Number of Catheter-Related Blood Stream Infections | 1 infections |
p-value: 0.17t-test, 2 sided