Blood Stream InfectionsNCT01409772
Evaluation of 70% Ethanol Lock Solution to Prevent Catheter Related Blood Stream Infections in Pediatric Patients
An observational study of Blood Stream Infections and Short Bowel Syndrome, run by University of Nebraska.
Trial summary
The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Blood Stream Infections, Short Bowel Syndrome
- What is being tested?
- Ethanol Lock
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2009to 9 Jul 2009
- Phase
- Observational
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Short Bowel Syndrome
Who may be able to join
- Signed informed consent/assent and willingness to adhere to protocol
- Intestinal rehabilitation patients with documented short bowel syndrome
- Age: newborn to 19 years of age
- Indwelling tunneled venous catheter placed for the purpose of total parenteral nutrition/IV fluids, with a 2 hour or longer window out of 24 hours for ethanol lock instillation
- No history of alcohol abuse
- No history of hypersensitivity to ethanol
- No history or documented active seizure disorder
Who cannot join
- Parent/guardian unwilling to sign consent
- Active bacterial infection
- Non-tunneled, non-permanent catheter (triple lumen or PICC)
- Pre-existing condition that would prevent enrollment as determined by each patients' physician
- Inability to adhere to protocol
About this study
Official title: Evaluation of the Clinical Practice of Using of a 70 % Ethanol Lock Solution for the Prevention of Catheter Related Blood Stream Infections in Pediatric Patients Undergoing Intestinal Rehabilitation
The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition.
Read the detailed description
Catheter- related blood stream infections are a serious complication for pediatric patients receiving parenteral nutrition. The leading causes of death in infants with short bowel syndrome (SBS) who are being treated with parenteral nutrition are central line sepsis and liver failure associated with the prolonged use of parenteral nutrition. (Cuffari, 2006) Incidence of infection ranges from 3% to 60% over the life span of each catheter. (Fratino, 2002) Interruption of nutritional support, antibiotic resistance and septic complications resulting from frequent infections can be life threatening to this fragile patient population. This patient population is dependent upon maintenance of central venous access for survival. Frequent hospitalizations, loss of work, and financial complications result in decreased quality of life for these patients and their caretakers. The cost of hospital treatment of catheter related bloodstream infections (CRBSI) has been estimated to range from $4000 to $56,000 for each occurrence. (MMWR 2002)
Vascular access sites are also limited in the pediatric population, and removal of central access for infection may diminish future ability to provide vital parenteral nutrition.(MMWR, 2002) Therefore, improvements in the ability to prevent infection are of utmost importance in this patient population.
The concept of antibiotic lock technique was developed in the late 1980s and was derived from various heparin lock protocols. Antibiotic locks have been used for both management and prevention of infection in vascular access devices. Antimicrobial choices for use in the antibiotic lock technique are dependent on the different pathogens suspected to infect the catheter lumen, characteristics of the organisms, and the pharmacodynamic properties of the antimicrobial agent. There is a risk of selection for multi-drug resistant organisms when antibiotic locks are utilized. In addition, heparin must be added to an antibiotic lock solution to maintain catheter patency.
More recently, ethanol locks have been utilized as a treatment option for children with CRBSIs. Ethanol is not only bactericidal and fungicidal in nature but also reveals thrombolytic properties. (Mouw, 2008) The thrombolytic properties eliminate the need for heparin addition to maintain catheter patency. Although utilized as treatment, ethanol is not currently being used for CRBSI prevention at our institution. Along with decreasing the risk of emerging antibiotic resistance, the investigators are attempting to determine if using ethanol as a lock solution will diminish the number of infections in the Intestinal Rehabilitation Program population, leading to decreased patient complications and costs. UNMC has the largest population of Intestinal Rehabilitation Program participants in the country making this a uniquely well-suited clinic in which to gather data surrounding this emerging infection-prevention strategy.
- Conditions
- Blood Stream Infections, Short Bowel Syndrome
- Being tested
- Ethanol Lock
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol LockDrug
Also called 70% ethanol
Ethanol Lock
| Study group | Role | What they receive |
|---|---|---|
| Intestinal Rehab | Pediatric Patients Undergoing Intestinal Rehabilitation for short bowel syndrome Receives: Drug: Ethanol Lock |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day infection rate prior to enrollment
To determine the 90 day infection rate in eligible subjects for the term immediately prior to enrollment in the study protocol.
Measured: 90 days
Secondary outcomes (2)
90 day CRBSI rate
90 day CRBSI rate in enrolled subjects.
Measured: 90 days
Organism and Treatment in CRBSI
Type of organism involved in CRBSI, and the treatment strategy used for each infection.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMay 2009 (estimated)
- Primary completion9 Jul 2009
- Study completion9 Jul 2009
Why it stopped: PI decided to withdraw study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kari A Simonsen, MD, Principal investigator, UNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409772
- Sponsor's protocol ID
- 0156-09-FB
- Status last verified
- Aug 2023
- First submitted
- 22 May 2009
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Practice of Using of a 70 % Ethanol Lock Solution for the Prevention of Catheter Related Blood Stream Infections in Pediatric Patients Undergoing Intestinal Rehabilitation
- ClinicalTrials.gov ID
- NCT01409772
- Acronym / sponsor ID
- 0156-09-FB
- Conditions
- Blood Stream Infections, Short Bowel Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI decided to withdraw study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- May 2009 (estimated)
- Primary completion
- 9 Jul 2009 (actual)
- Study completion
- 9 Jul 2009 (actual)
- First posted
- 4 Aug 2011 (estimated)
- 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.
The purpose of this study is to evaluate the clinical practice of the prophylactic use of ethanol locks for the prevention of catheter related blood stream infections in pediatric intestinal rehabilitation program patients requiring total parenteral nutrition.
Detailed description
Catheter- related blood stream infections are a serious complication for pediatric patients receiving parenteral nutrition. The leading causes of death in infants with short bowel syndrome (SBS) who are being treated with parenteral nutrition are central line sepsis and liver failure associated with the prolonged use of parenteral nutrition. (Cuffari, 2006) Incidence of infection ranges from 3% to 60% over the life span of each catheter. (Fratino, 2002) Interruption of nutritional support, antibiotic resistance and septic complications resulting from frequent infections can be life threatening to this fragile patient population. This patient population is dependent upon maintenance of central venous access for survival. Frequent hospitalizations, loss of work, and financial complications result in decreased quality of life for these patients and their caretakers. The cost of hospital treatment of catheter related bloodstream infections (CRBSI) has been estimated to range from $4000 to $56,000 for each occurrence. (MMWR 2002)
Vascular access sites are also limited in the pediatric population, and removal of central access for infection may diminish future ability to provide vital parenteral nutrition.(MMWR, 2002) Therefore, improvements in the ability to prevent infection are of utmost importance in this patient population.
The concept of antibiotic lock technique was developed in the late 1980s and was derived from various heparin lock protocols. Antibiotic locks have been used for both management and prevention of infection in vascular access devices. Antimicrobial choices for use in the antibiotic lock technique are dependent on the different pathogens suspected to infect the catheter lumen, characteristics of the organisms, and the pharmacodynamic properties of the antimicrobial agent. There is a risk of selection for multi-drug resistant organisms when antibiotic locks are utilized. In addition, heparin must be added to an antibiotic lock solution to maintain catheter patency.
More recently, ethanol locks have been utilized as a treatment option for children with CRBSIs. Ethanol is not only bactericidal and fungicidal in nature but also reveals thrombolytic properties. (Mouw, 2008) The thrombolytic properties eliminate the need for heparin addition to maintain catheter patency. Although utilized as treatment, ethanol is not currently being used for CRBSI prevention at our institution. Along with decreasing the risk of emerging antibiotic resistance, the investigators are attempting to determine if using ethanol as a lock solution will diminish the number of infections in the Intestinal Rehabilitation Program population, leading to decreased patient complications and costs. UNMC has the largest population of Intestinal Rehabilitation Program participants in the country making this a uniquely well-suited clinic in which to gather data surrounding this emerging infection-prevention strategy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intestinal Rehab | – | Drug: Ethanol LockPediatric Patients Undergoing Intestinal Rehabilitation for short bowel syndrome |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Short Bowel Syndrome
Key inclusion criteria (7 listed)
- Signed informed consent/assent and willingness to adhere to protocol
- Intestinal rehabilitation patients with documented short bowel syndrome
- Age: newborn to 19 years of age
- Indwelling tunneled venous catheter placed for the purpose of total parenteral nutrition/IV fluids, with a 2 hour or longer window out of 24 hours for ethanol lock instillation
- No history of alcohol abuse
Key exclusion criteria (5 listed)
- Parent/guardian unwilling to sign consent
- Active bacterial infection
- Non-tunneled, non-permanent catheter (triple lumen or PICC)
- Pre-existing condition that would prevent enrollment as determined by each patients' physician
- Inability to adhere to protocol
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 |
|---|---|---|
| Ethanol LockAlso: 70% ethanolEthanol Lock | Drug | Intestinal Rehab |
Primary outcome
90 day infection rate prior to enrollment
Time frame: 90 days
To determine the 90 day infection rate in eligible subjects for the term immediately prior to enrollment in the study protocol.
2 secondary outcomes
90 day CRBSI rate
Time frame: 90 days
Organism and Treatment in CRBSI
Time frame: 90 days
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 22 Aug 2023.
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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.
Kari A Simonsen, MD principal investigator
UNMC
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stream Infections and Short Bowel Syndrome, run by University of Nebraska.
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 7 inclusion and 5 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 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
90 day infection rate prior to enrollment (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.