Use of a Novel Catheter Lock Solution For Treatment of Hemodialysis Catheter Infections

• Sponsor: University of California, San Diego (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01483872
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy.

The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.

Condition or Disease	Intervention/Treatment	Phase
Infection; Dialysis Catheter	Drug: NAC/Tigecycline/Heparin combination lock solution; Drug: Standard anticoagulant (Heparin or Citrate)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia.
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAC/Tigecycline/Heparin combination lock solution A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter	Drug: NAC/Tigecycline/Heparin combination lock solution
Placebo Comparator: Standard anticoagulant (heparin or citrate) Standard anticoagulant (heparin or citrate)	Drug: Standard anticoagulant (Heparin or Citrate)

Outcome Measures

Primary Outcome Measures

1. Success Rate [90 days]

   Nine participants signed consent forms, only one randomized. Data was not analyzed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any adult (≥ 18 years of age) who has ESRD and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment.

Exclusion Criteria:

• The following patients will be excluded from study entry:

1. patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and

2. patient is allergic to NAC, tigecycline, minocycline, or heparin.

The following patients will be excluded from randomization:

1. patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors,

2. patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema,

3. patient is pregnant or will become pregnant,

4. the infection is due to an organism that is resistant to tigecycline such as Candida or Pseudomonas species.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD Medical Center	San Diego	California	United States	92103

Sponsors and Collaborators

• University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saima Aslam, Asst Adjunct Prof, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT01483872
• Other Study ID Numbers: 101094
• First Posted: Dec 2, 2011
• Last Update Posted: Sep 6, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Saima Aslam, Asst Adjunct Prof, University of California, San Diego: salvage infected hemodialysis catheters; novel catheter lock solution
• Additional relevant MeSH terms: Infections; Tigecycline; Heparin; Calcium heparin; Anticoagulants

Study Results

Participant Flow

Pre-assignment Detail	9 patients signed consent forms. Only one developed an active infection and thus underwent randomization.

Arm/Group Title	NAC/Tigecycline/Heparin Combination Lock Solution	Standard Anticoagulant (Heparin or Citrate)
Arm/Group Description	A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter NAC/Tigecycline/Heparin combination lock solution	Standard anticoagulant (heparin or citrate) Standard anticoagulant (Heparin or Citrate)
Period Title: Overall Study
STARTED	0	1
COMPLETED	0	1
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 44.4%
>=65 years	5 55.6%
Sex: Female, Male (Count of Participants)
Female	2 22.2%
Male	7 77.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 11.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 11.1%
White	5 55.6%
More than one race	0 0%
Unknown or Not Reported	2 22.2%

Outcome Measures

1. Primary Outcome

Title	Success Rate
Description	Nine participants signed consent forms, only one randomized. Data was not analyzed.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Nine participants signed consent forms, only one randomized. Data was not analyzed.

Arm/Group Title	All Participants
Arm/Group Description	Nine participants signed consent forms, only one randomized. Data was not analyzed.
Measure Participants	0

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Nine participants signed consent forms, only one randomized. Data was not analyzed.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

Nine participants signed consent forms, only one randomized. Study terminated due to low enrollment. Data was not analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.