UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049994 |
|---|---|
| Receipt number | R000056940 |
| Scientific Title | Study on the prediction of fluid responsiveness using the change in peripheral perfusion index to phenylephrine |
| Date of disclosure of the study information | 2023/01/09 |
| Last modified on | 2024/03/14 14:53:25 |
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Basic information
Public title
Study on the prediction of fluid responsiveness using the change in peripheral perfusion index to phenylephrine.
Acronym
Study on the prediction of fluid responsiveness using the change in peripheral perfusion index to phenylephrine
Scientific Title
Study on the prediction of fluid responsiveness using the change in peripheral perfusion index to phenylephrine
Scientific Title:Acronym
Study on the prediction of fluid responsiveness using the change in peripheral perfusion index to phenylephrine
Region
| Japan |
Condition
Condition
Patients scheduled for elective surgery with general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the ability to predict fluid responsiveness of the change in the peripheral perfusion index (PI) in response to 0.1 mg of phenylephrine is investigated. Fluid responder is determined by SVV >12%.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in PI (pre, 1 minute, 2 minutes post-infusion) in response to a 0.1 mg of phenylephrine as a predictor of infusion responsiveness.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Scheduled surgical patients undergoing general anaesthesia with arterial pressure line placement
Key exclusion criteria
Patients with cardiac ejection fraction below 40%
patients with atrial fibrillation
patients with severe COPD
patients with right heart failure
patients with severe obesity (BMI > 35)
patients with emaciation (BMI < 15)
patients with peripheral artery disease
patients on dialysis
patients with preoperative hyperthyroidism
patients with bradycardia (heart rate < 50 beats/min)
patients scheduled for brachial plexus block
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Iizuka |
Organization
Jichi medical university, saitama medical center
Division name
department anesthesiology and critical care medicine
Zip code
330-8503
Address
1-847, Amanuma town, Omiya Ku, Saitama CIty, Saitama, Japan
TEL
+81486472111
zukarinn@gmail.com
Public contact
Name of contact person
| 1st name | Ifumi |
| Middle name | |
| Last name | Takeuchi |
Organization
Jichi medical university, saitama medical center
Division name
Department of Clinical Trial Promotion
Zip code
3308503
Address
1-847, Amanuma town, Omiya Ku, Saitama CIty, Saitama, Japan
TEL
0486472111
Homepage URL
zukarinn@gmail.com
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Yusuke Iizuka
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
Jichi medical university, saitama medical center
Address
1-847, Amanuma town, Omiya Ku, Saitama CIty, Saitama, Japan
Tel
+81486472111
s-suishin@jichi.ac.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
自治医科大学附属さいたま医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10908037/pdf/12871_2024_Article_2478.pdf
Number of participants that the trial has enrolled
42
Results
42 patients were included in this study. The stroke volume (SV) in patients with preload dependency (n=23) increased after phenylephrine administration. However, phenylephrine administration did not impact the SV in patients without preload dependency (n=19). The perfusion index (PI) decreased regardless of preload dependency. The changes in the PI after phenylephrine administration exhibited low accuracy for predicting preload dependency.
Results date posted
| 2024 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 02 | Day |
Baseline Characteristics
Patients older than 18 years who were scheduled for surgery and who underwent radial artery catheter placement and cardiac output monitoring between January and April 2023 were included in this study. Exclusion criteria were severe preoperative lung disease (Chronic Obstructive Pulmonary Disease clinical stage of Global Initiative for Chronic Obstructive Lung Disease 3 or 4 or a history of lung resection), left ventricular ejection fraction of less than 40%, atrial fibrillation, right heart failure (suspected pulmonary hypertension or elevated central venous pressure), obesity (body mass index above 35 kg/m2), emaciation (body mass index less than 15 kg/m2), peripheral artery disease, haemodialysis, hyperthyroidism, bradycardia (HR less than 50 bpm/min), and brachial plexus block administration
Participant flow
This was a non-invasive observational study and prior written consent was not required by the Ethics Committee. Patients were included in the study if they had a mean arterial pressure of 65 mmHg after induction of general anesthesia and before the start of surgery.
Adverse events
none
Outcome measures
Does the rate of change in PI (1 and 2 minutes after administration) predict preload dependence (SVV above 12%) after administration of 0.1 mg of phenylephrine when mean blood pressure is less than 65 mmHg?
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Between tracheal intubation and skin incision, if the mean arterial pressure falls below 65 mmHg, the BIS value, systolic pressure, mean arterial pressure, diastolic pressure, heart rate, CI, SV, SVV, PPV, stroke volume, PI and PVI are recorded, and 0.1 mg phenylephrine is administered. Record the values 1 and 2 minutes after administration, respectively. During this 2-minute period, any changes in position, anaesthetic depth or other administration of vasoactive drugs should not be allowed.
Management information
Registered date
| 2023 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056940
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