UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012311 |
|---|---|
| Receipt number | R000014396 |
| Scientific Title | Evaluation of less invasive hemodynamic monitoring in optimizing preoperative management of PIH patients undergoing cesarean section |
| Date of disclosure of the study information | 2013/11/15 |
| Last modified on | 2013/11/15 17:19:36 |
* 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
Evaluation of less invasive hemodynamic monitoring in optimizing preoperative management of PIH patients undergoing cesarean section
Acronym
less invasive hemodynamic monitoring in PIH patients for cesarean section
Scientific Title
Evaluation of less invasive hemodynamic monitoring in optimizing preoperative management of PIH patients undergoing cesarean section
Scientific Title:Acronym
less invasive hemodynamic monitoring in PIH patients for cesarean section
Region
| Japan |
Condition
Condition
pregnancy induced hypertension
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives of this study is to evaluate the utility of less invasive hemodinamic monitoring (FloTrac) in PIH patients undergoing cesarean section
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of pulmonary edema
Key secondary outcomes
in-out balance, urine output, oxygenation index, serum creatinine, dose of antihypertensive agent
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment of oliguria by fluid administration based on arterial pulse-wave analysis for cardiac output and stroke volume variation assessment as well as Cardiac output and blood volume measurement by dyedensitogram.
Interventions/Control_2
Routine postoperative care for oliguria
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
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
PIH patients undergoing cesarean section
Key exclusion criteria
patients refusal
co-morbidity other than PIH
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuo Terui |
Organization
Saitama Medical Center
Division name
Division of Obstetric Anesthesia
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3654
terui@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Yoshitomi |
Organization
Saitama Medical Center
Division name
Division of Obstetric Anesthesia
Zip code
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3654
Homepage URL
adam_eve_asia1@hotmail.com
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Saitama Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2013 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014396
