Unique ID issued by UMIN | UMIN000035392 |
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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 |
Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Contamination of blood cultures from arterial catheters (CONTACT study)
Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Contamination of blood cultures from arterial catheters (CONTACT study)
Japan |
Suspected bacteremia in adult critically ill patients
Intensive care medicine |
Others
NO
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.
Bio-equivalence
Not applicable
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).
The volumes of collected blood; the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value and negative predictive value of true bacteremia
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
590
1st name | Izumi |
Middle name | |
Last name | Nakayama |
Okinawa Chubu Hospital
Intensive Care Unit
904-2293
281 Miyazato, Uruma, Okinawa 904-2293, Japan
098-973-4111
izunakayama-circ@umin.org
1st name | Izumi |
Middle name | |
Last name | Nakayama |
Okinawa Chubu Hospital
Intensive Care Unit
904-2293
281 Miyazato, Uruma, Okinawa 904-2293, Japan
098-973-4111
izunakayama-circ@umin.org
Okinawa Chubu Hospital, Intensive Care Unit
None
Self funding
Sakai City Medical Center
Kameda General Hospital
Musashino Red Cross Hospital
Kobe City Medical Center General Hospital
Okinawa Chubu Hospital Research ethics committees
281 Miyazato, Uruma, Okinawa, Japan
0989734111
miyazato_chikako@hosp.pref.okinawa.jp
NO
沖縄県立中部病院(沖縄県)
2018 | Year | 12 | Month | 29 | Day |
protocol is currently unavailable
Published
https://journal.chestnet.org/article/S0012-3692(23)00161-7/fulltext
590
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%).
2023 | Year | 07 | Month | 05 | Day |
Results will be available after publication.
2023 | Year | 01 | Month | 29 | Day |
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%.
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.
No adverse events was observed.
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.
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.
As above.
Main results already published
2018 | Year | 12 | Month | 02 | Day |
2018 | Year | 12 | Month | 27 | Day |
2018 | Year | 12 | Month | 29 | Day |
2021 | Year | 12 | Month | 26 | Day |
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.
2018 | Year | 12 | Month | 28 | Day |
2023 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040169
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