UMIN-CTR Clinical Trial

Basic information
Public title	Detecting central-venous oxygen saturation without a central-venous catheter: Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial - multi-center prospective observational study.
Acronym	Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting ScvO2
Scientific Title	Detecting central-venous oxygen saturation without a central-venous catheter: Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial - multi-center prospective observational study.
Scientific Title:Acronym	Diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting ScvO2
Region	Japan

Condition
Condition	Patients with shock
Classification by specialty	Emergency medicine Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the diagnostic accuracy of the difference between systolic arterial blood pressures invasively measured at radial and non-invasively measured at brachial for detecting whether central venous saturation is lower than 70% among patients with shock.
Basic objectives2	Others
Basic objectives -Others	Observational study to evaluate diagnostic accuracy
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Whether central venous saturation is lower than 70% at the first measurement.
Key secondary outcomes	Whether central venous saturation is lower than 70% at the 6 hour later from first measurement. Whether central venous saturation is lower than 65% at the first measurement. Whether central venous saturation is lower than 65% at the 6 hour later from first measurement.

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	all patients who meet following criteria 1) patients who are admitted to Intensive Care Units 2) patients whose systolic blood pressure measured by invasively at radial(ABPs) gets down under 90 mm Hg 3) patients who meet the following shock criteria definition of shock: need vasopressor requirement to maintain a mean arterial blood pressure of 65 mm Hg and or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia.
Key exclusion criteria	1) patients who are younger than 16 years old 2) patients who have shunt 3) patients who have arteriovenous shunt 4) patients who withdrew from resuscitation 5) patients who are expected to die within 6 hours
Target sample size	178

Research contact person
Name of lead principal investigator	1st name Junji Middle name Last name Kumasawa
Organization	Sakai City Medical Center
Division name	Department of Critical Care Medicine
Zip code	593-8304
Address	1-1-1, Ebaraji-cho, Nishi-ku, Sakai City, Osaka, Japan
TEL	072-272-1199
Email	jkumakumakuma@hotmail.com

Public contact
Name of contact person	1st name Junji Middle name Last name Kumasawa
Organization	Sakai City Medical Center
Division name	Department of Critical Care Medicine
Zip code	593-8304
Address	1-1-1, Ebaraji-cho, Nishi-ku, Sakai City, Osaka, Japan
TEL	072-272-1199
Homepage URL
Email	jkumakumakuma@hotmail.com

Sponsor
Institute	Sakai City Medical Center Department of Critical Care Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sakai City Medical Center
Address	1-1-1, Ebaraji-cho, Nishi-ku, Sakai, Osaka, Japan
Tel	0722721199
Email	none

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

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 20 Day

Related information
URL releasing protocol	none
Publication of results	Unpublished

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	120
Results	On going
Results date posted	2021 Year 08 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	On going
Participant flow	On going
Adverse events	None
Outcome measures	On going
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 28 Day
Date of IRB	2016 Year 12 Month 28 Day
Anticipated trial start date	2017 Year 09 Month 28 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry	2020 Year 04 Month 01 Day
Date trial data considered complete	2020 Year 04 Month 01 Day
Date analysis concluded	2021 Year 04 Month 01 Day

Other

Other related information

Arterial blood pressure is measured using an arterial catheter in a radial artery. The catheter is connected to a pressure transducer or flotrac. The transducer is zeroed to atmospheric pressure and referenced to the midaxillary line with the patient in the supine position. On the same side as the radial-artery catheter, noninvasively measured brachial blood pressure (NIBP) is measured by oscillometry wit a brachial cuff. The size of the cuff is chosen according to recent guidelines. NIBP is measured consecutively three times, and the mean is recorded. These measurements are recorded at two point, after the admission to ICU and the 6 hours later. We use "delta-BP" to refer to the difference between ABPs and NIBPs (ie, ABPs minus NIBPs). We also record each patient's age, sex, cause of admission, heart rate, blood pressure (systolic, diastolic, and mean, from both invasive and noninvasive measurements), use of mechanical ventilation, Acute Physiology and Chronic Health Evaluation II score, Sequential Organ Failure Assessment score, cardiac output/cardiac index, systemic vascular resistance, hemoglobin level, arterial blood oxygen saturation, partial pressure of arterial and central venous carbon dioxide, lactate level and measurements of echocardiography (ejection fraction, diastolic left ventricular diameter and systolic left ventricular diameter). Statistical analysis. We perform logistic regression analysis as delta-BP is independent variable and ScvO2 < 70%, which is measured at first measurement, is dependent variable. We calculate the area under the ROC curve for delta-BP as an indicator of ScvO2 < 70%. As pre-defined sub analysis, we performed logistic analysis with using the sub set which exclude patients who are underwent cardiac surgery and are arrested. We calculate Spearmen's rank correlation between delta-BP and SVR, CO or CI. We use STATA version 13 (STATA, College Station, TX).

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2021 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026889