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Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates

Primary Purpose

Septicemia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
aspirating first blood volume into a regular blood collection tube
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septicemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).

Exclusion Criteria:

  • None

Sites / Locations

  • Hadassah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial Specimen Diversion

Standard practice

Arm Description

Aspirating first blood volume into a regular blood collection tube

Aspirating first blood into blood culture bottles (Standard practice)

Outcomes

Primary Outcome Measures

Blood culture contamination rate
A blood culture contamination is defined as growth in a single set of coagulase-negative Staphylococcus, Micrococcus, Viridans group Streptococcus, Propionibacterium acne, Corynebacterium sp (diphtheroids) or Bacillus sp.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2017
Last Updated
July 28, 2020
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT03088865
Brief Title
Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates
Official Title
Evaluation of an Internal Hospital Practice: The Effect of Altered Sampling Protocol on Blood Culture Contamination Rates: An Open, Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septicemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
756 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial Specimen Diversion
Arm Type
Experimental
Arm Description
Aspirating first blood volume into a regular blood collection tube
Arm Title
Standard practice
Arm Type
Active Comparator
Arm Description
Aspirating first blood into blood culture bottles (Standard practice)
Intervention Type
Diagnostic Test
Intervention Name(s)
aspirating first blood volume into a regular blood collection tube
Intervention Description
order of blood drawing
Primary Outcome Measure Information:
Title
Blood culture contamination rate
Description
A blood culture contamination is defined as growth in a single set of coagulase-negative Staphylococcus, Micrococcus, Viridans group Streptococcus, Propionibacterium acne, Corynebacterium sp (diphtheroids) or Bacillus sp.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry). Exclusion Criteria: None
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
31539635
Citation
Lalezari A, Cohen MJ, Svinik O, Tel-Zur O, Sinvani S, Al-Dayem YA, Block C, Moses AE, Oster Y, Salameh S, Strahilevitz J. A simplified blood culture sampling protocol for reducing contamination and costs: a randomized controlled trial. Clin Microbiol Infect. 2020 Apr;26(4):470-474. doi: 10.1016/j.cmi.2019.09.005. Epub 2019 Sep 17.
Results Reference
derived

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Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates

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