NCT00885300

Brief Summary

The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

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

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

6 months

First QC Date

April 20, 2009

Last Update Submit

April 20, 2009

Conditions

Double Lumen InfectionHemodialysis

Outcome Measures

Primary Outcomes (1)

  • catheter infection

    6 months

Study Arms (2)

1

EXPERIMENTAL

cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis

Drug: cloxacillinDrug: heparin

2

ACTIVE COMPARATOR

heparin 1000iu/ml as catheter lock at the end of hemodialysis

Drug: heparin

Interventions

cloxacillinDRUG

cloxacillin 100mg/ml as catheter lock at the end of hemodialysis

1
heparinDRUG

heparin 1000iu/ml as catheter lock at the end of hemodialysis

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemodialysis for 3 months
  • at least 2 time dialysis/week

You may not qualify if:

  • active infection
  • acute renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University Hemodialysis Center

Shiraz, Fars, o98-711, Iran

Location

Related Publications (1)

  • Unver S, Atasoyu EM, Evrenkaya TR, Ardic N, Ozyurt M. Risk factors for the infections caused by temporary double-lumen hemodialysis catheters. Arch Med Res. 2006 Apr;37(3):348-52. doi: 10.1016/j.arcmed.2005.07.010.

    PMID: 16513483BACKGROUND

MeSH Terms

Interventions

CloxacillinHeparin

Intervention Hierarchy (Ancestors)

OxacillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • maryam pakfetart, assistant professor

    Shiraz nephro-urology research center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

IR(1)