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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003221
Receipt No. R000003901
Scientific Title Reproducibility of hemodynamic and respiratory parameters using the PiCCO monitoring system in patients with post-cardiac arrest syndrome
Date of disclosure of the study information 2010/02/21
Last modified on 2012/02/21

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Basic information
Public title Reproducibility of hemodynamic and respiratory parameters using the PiCCO monitoring system in patients with post-cardiac arrest syndrome
Acronym PiCCO-CPA-DATA
Scientific Title Reproducibility of hemodynamic and respiratory parameters using the PiCCO monitoring system in patients with post-cardiac arrest syndrome
Scientific Title:Acronym PiCCO-CPA-DATA
Region
Japan

Condition
Condition Patients with post-cardiac arrest syndrome
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to determine the reproducibility of hemodynamic and respiratory parameters using the PiCCO monitoring system in patients with post-cardiac arrest syndrome
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate the intraclass correlation coefficients of Cardiac Output, Global End Diastolic Volume, ExtraVascular Lung Water, Pulmonary Vascular Permeability Index obtained from the PiCCO monitoring system in patient with post-cardiac arrest syndrome.
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
15 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients in cardiac arrest on arrival at hospital. Regardless of the presence of recovery of spontaneous circulation (ROSC) before arrival.
2) Patients resuscitated by 2005 American Heart Association Guideline for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.
3) Regardless of existence or nonexistence of witness.
4) Regardless of with or without bystander cardiopulmonary resuscitation (CPR).
Key exclusion criteria 1) Patients aged below 15
2) Patients in cardiac arrest associated with terminal stage of cancer.
3) Patients in cardiac arrest due to cerebrovascular disease.
4) Patients in cardiac arrest due to aortic dissection or aortic aneurysm
5) Family or other agents refuse to the registry of patient.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tagami,MD
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Tagami,MD
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL
Homepage URL
Email

Sponsor
Institute Aizu chuo hospital
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 21 Day

Related information
URL releasing protocol http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2011.06981.x/abstract
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2044.2011.06981.x/abstract
Number of participants that the trial has enrolled
Results
Anaesthesia 2012, 67, 236
The aim of the present study was to determine the precision of the PiCCO&#174; system for post-cardiac arrest patients who underwent therapeutic hypothermia. The precision of the measurements for cardiac output, global end-diastolic volume, extravascular lung water and the pulmonary vascular permeability index was assessed using the least significant change; this was regarded as precise when less than 15%. A total of 462 measurement sets were prospectively performed on 88 patients following successful resuscitation after cardiac arrest. Using the mean value of three injections for a measurement, the least significant change for the cardiac output, global end-diastolic volume, extravascular lung water and pulmonary vascular permeability index measurements were found to be 7.8%, 8.5%, 7.8% and 12.1%, respectively. No significant differences between hypothermia (n = 150) and non-hypothermia (n = 312) were found. The PiCCO-derived variables were found to be precise for post-cardiac arrest patients even under conditions of varying body temperature. 
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
2008 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2010 Year 07 Month 01 Day
Date of closure to data entry
2010 Year 07 Month 01 Day
Date trial data considered complete
2010 Year 07 Month 01 Day
Date analysis concluded
2010 Year 08 Month 01 Day

Other
Other related information Thermal noise, including hypothermia and short-term variations in body temperature, has been reported to influence the accuracy and reproducibility of thermodilution measurements. We determine the influence of thermal noise during therapeutic hypothermia derived from arterial thermal dilution using the PiCCO&reg; system in patients with post-cardiac arrest syndrome.

Management information
Registered date
2010 Year 02 Month 21 Day
Last modified on
2012 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003901

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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