UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035392 |
|---|---|
| Receipt number | R000040169 |
| Scientific Title | Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study |
| Date of disclosure of the study information | 2018/12/29 |
| Last modified on | 2023/07/05 16:54:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Acronym
Contamination of blood cultures from arterial catheters (CONTACT study)
Scientific Title
Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Scientific Title:Acronym
Contamination of blood cultures from arterial catheters (CONTACT study)
Region
| Japan |
Condition
Condition
Suspected bacteremia in adult critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the contamination of blood cultures drawn from arterial catheters is non-inferior to that of blood cultures drawn from peripheral venipuncture in adult critically ill patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportions of blood culture contamination
Assessment of the primary outcome: every positive blood culture will be evaluated with two staff infectious disease specialists who will be blinded to the source of the blood culture (arterial catheters or skin puncture).
Key secondary outcomes
The volumes of collected blood; the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value and negative predictive value of true bacteremia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Blood cultures collected during clinically suspected episodes of bacteremia AND
1. Obtained from adult (20 years or older) critically ill patients
2. A paired blood culture sets, consisting of one blood culture set drawn from existing arterial catheters and one blood culture set drawn from peripheral skin punctures.
All blood cultures obtained from adult critically ill patients will be screened for eligibility during the study period. All consecutive blood culture sets will be enrolled if they fulfill the inclusion criteria and none of the exclusion criteria.
Key exclusion criteria
1. Obtained from arterial lines without a closed blood sampling system
2. Percutaneous procedures (PCI, IVR) had performed through the arterial line
3. Inappropriately labeled blood cultures
4. Enrolled in this study previously
5. Refusal of study participation
Target sample size
590
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Nakayama |
Organization
Okinawa Chubu Hospital
Division name
Intensive Care Unit
Zip code
904-2293
Address
281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL
098-973-4111
izunakayama-circ@umin.org
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Nakayama |
Organization
Okinawa Chubu Hospital
Division name
Intensive Care Unit
Zip code
904-2293
Address
281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL
098-973-4111
Homepage URL
izunakayama-circ@umin.org
Sponsor or person
Institute
Okinawa Chubu Hospital, Intensive Care Unit
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sakai City Medical Center
Kameda General Hospital
Musashino Red Cross Hospital
Kobe City Medical Center General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okinawa Chubu Hospital Research ethics committees
Address
281 Miyazato, Uruma, Okinawa, Japan
Tel
0989734111
miyazato_chikako@hosp.pref.okinawa.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
沖縄県立中部病院(沖縄県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
protocol is currently unavailable
Publication of results
Published
Result
URL related to results and publications
https://journal.chestnet.org/article/S0012-3692(23)00161-7/fulltext
Number of participants that the trial has enrolled
590
Results
Of 1655 episodes of blood culture from December 2018 to July 2021, 590 paired blood cultures were enrolled, and 6.9% episodes had true bloodstream infection. In blood cultures from arterial catheters, 6.0% were positive, and 0.3% were contaminated; in venipuncture, 6.1% were positive, and 0.7% were contaminated. The estimated difference in contamination proportion (arterial catheter - venipuncture) was -0.3% (upper limit of one-sided 95% confidence interval [CI], +0.3%).
Results date posted
| 2023 | Year | 07 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Results will be available after publication.
Date of the first journal publication of results
| 2023 | Year | 01 | Month | 29 | Day |
Baseline Characteristics
The patients' median age was 69 (IQR, 57to77) years 69% were male, and 92% were emergent ICU admissions. In-hospital mortality was 29%. At the time of blood culture collection, the median days from ICU admission was 2.0 days and classic signs of bloodstream infection were present as follows fever (38.3celsius), 27%, rigors, 6.7%, hypotension (systolic blood pressure 90 mmHg), 8%.
Participant flow
Between December 2018 and July 2021, 1655 episodes of blood cultures were collected from critically ill adult patients. Of these, 1439 episodes had an indwelling arterial catheter placed and 838 episodes had eligible paired blood cultures, which consisted of one blood culture set drawn from arterial catheters and another from peripheral venipuncture. After excluding 248 episodes, we enrolled 590 episodes of paired blood culture collection from 590 unique patients with suspected bloodstream infection.
Adverse events
No adverse events was observed.
Outcome measures
The primary measure to quantify blood culture contamination was the contamination proportion, defined as a proportion obtained by dividing the number of false-positive results with the total number of blood culture collection procedures.
Plan to share IPD
The data that support the findings of this study are available from Okinawa Prefectural Chubu Hospital, but are not publicly available. However, data are available from the authors upon reasonable request and with the permission of the institution.
IPD sharing Plan description
As above.
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sample size calculation: This study is designed to investigate whether the contamination proportions of blood cultures drawn from arterial catheters are noninferior to those of blood cultures drawn from skin punctures. The calculated sample size is 590 paired blood culture sets based on a noninferiority margin of 2% for an absolute increase in the contamination proportions of arterial catheter blood cultures versus skin puncture blood cultures, a 1-sided alpha of 5%, and 80% power, assuming a baseline contamination proportion of 1.6%. A noninferiority margin of 2% was set based on the recommendation from Clinical and Laboratory Standards institute (recommended proportion of contamination <3%). A baseline contamination proportion of 1.6% was set based on the average contamination proportions of the study sites over the previous year. If additional study sites included, we will plan to enroll 650 paired blood culture sets assuming a baseline contamination proportion of 1.8%.
Statistical analysis: We will declare noninferiority if the upper limit of the 1-sided 95% interval for the difference in proportions of contamination (the proportion of contamination in arterial catheter blood cultures minus the proportion of contamination in skin puncture blood cultures) is less than the noninferiority margin of 2%. As a pre-specified secondary analysis, we will examine the difference between collected blood volumes in arterial catheter blood cultures and in skin puncture blood cultures with t-test or nonparametric test.
Management information
Registered date
| 2018 | Year | 12 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040169
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
