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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011421
Receipt No. R000013343
Scientific Title The influence of perioperative albumin administration to peripheral vascular permeability and extravascular lung water
Date of disclosure of the study information 2013/08/08
Last modified on 2015/08/24

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Basic information
Public title The influence of perioperative albumin administration to peripheral vascular permeability and extravascular lung water
Acronym Perioperative albumin administration
Scientific Title The influence of perioperative albumin administration to peripheral vascular permeability and extravascular lung water
Scientific Title:Acronym Perioperative albumin administration
Region
Japan

Condition
Condition post operation of oral cavity tumor
Classification by specialty
Oto-rhino-laryngology Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Fluid therapy and choice of fluid at the perioperative high permeability state is controversial. Our purpose is that whether the albumin administration affect to the extravascular lung water with using volume view catheter.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Primary outcomes is measurement of extravascular lung water and peripheral vascular permeability index at the timing of immediately, 3 hours and 6 hours after administration of albumin. Albumin administration and measurement is repeated 12 hours, 36 hours and 60 hours after operation.
Key secondary outcomes Secondary outcomes is measurement of hemodynamic parameters as following: Heart Rate, Blood Pressure, Cardiac output, Central Venous Pressure, Peripheral Vascular Resistance) and Blood Gas Analysis as following: pH, PaO2 and PaCO2). These measurement is implemented immediately, 3 hours and 6 hours after albumin administration.

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of the arterial line at the femoral artery. Extra vascular Lung water (EVLW) and peripheral vascular permeability index (PVPI) are measured as baseline at the timing of intensive care unit (ICU) admission. 25% albumin is given 12 hours, 36 hours and 60 hours after ICU admission. EVWL and PVPI are measured at immediately, 3 hours and 6 hours after albumin infusion.
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 Patients who require deep sedation for 72 hours at the intensive care unit after resection of oral cavity tumor and skin flap plasty.
Key exclusion criteria Patients who are under 18 years old and severe pulmonary disease with low respiratory function due to lung resection or chronic obstructive lung disease.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Takaki
Organization Yokohama City University Hospital
Division name Intensive Care Unit
Zip code
Address 3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture
TEL 045-787-2800
Email shunty5323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Takaki
Organization Yokohama City University Hospital
Division name Intensive Care Unit
Zip code
Address 3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture
TEL 080-2377-9787
Homepage URL
Email shunty5323@gmail.com

Sponsor
Institute Department of Anesthesiology Yokohama City University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology Yokohama City University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Perioperative albumin administration affect to extra lung water index, but this effect is widely varied depends on inflammatory status after operation.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 09 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 20 Day
Date trial data considered complete
2015 Year 05 Month 30 Day
Date analysis concluded
2015 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2015 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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