NCT00571259

Brief Summary

This is a randomized, double blinded, prospective, multicenter, clinical trial of the use of Heparin versus Gentamicin as a pos-dialysis catheter lock solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
11.7 years until next milestone

Results Posted

Study results publicly available

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

6.3 years

First QC Date

December 10, 2007

Results QC Date

March 15, 2021

Last Update Submit

September 21, 2021

Conditions

Bacteremia

Keywords

Sodium citrateGentamicinProphylaxisHemodialysisCentral venous catheter

Outcome Measures

Primary Outcomes (1)

  • Rate of Device-related Bacteremia

    Positive blood cultures in a patient whose vascular access is a central venous catheter without another obvious source of infection

    5 years

Secondary Outcomes (1)

  • Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow

    5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Catheter lock with heparin 1,000 units/mL

Drug: Heparin 1000U/mL

2

ACTIVE COMPARATOR

Catheter lock with gentamicin 320 micrograms/mL in sodium citrate 4%

Drug: 4% Sodium Citrate with Gentamicin 320 mcg/mL

Interventions

Heparin 1000U/mLDRUG

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

1
4% Sodium Citrate with Gentamicin 320 mcg/mLDRUG

A volume sufficient to fill the catheter length will be instilled in both catheter ports post dialysis

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Requires placement of a central venous catheter or currently has a central venous catheter for hemodialysis access.
  • Must be at least 18 years old
  • Compliant with a dialysis treatment schedule
  • Plans to continue hemodialysis treatment and follow-up at the investigational site
  • Must be able to care for the exit site independently or have someone who is able to care for the site for them
  • Must be able to sign the informed consent document

You may not qualify if:

  • The subject who has had an infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred
  • Active exit site or tunnel infection
  • Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening
  • Known to have antibodies to heparin
  • Allergy to pork heparin
  • Allergy to gentamicin
  • Subject is pregnant
  • Known intravenous drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satellite Healthcare, Inc

Mountain View, California, 94041, United States

Location

MeSH Terms

Conditions

Bacteremia

Interventions

HeparinSodium CitrateGentamicins

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAminoglycosidesGlycosides

Limitations and Caveats

The requirement for dialysis facility staff to prepare the treatment intervention prevented a completely blinded study.

Results Point of Contact

Title
Veronica Legg, MS: Director of Research Business
Organization
Satellite Healthcare, Inc.
leggv@satellitehealth.com
360-607-6892

Study Officials

  • Norman Coplon, MD

    Satellite Healthcare, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

September 1, 2003

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 22, 2021

Results First Posted

September 22, 2021

Record last verified: 2021-09

Locations

US(1)