UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003221 |
|---|---|
| Receipt number | 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 09:34:18 |
* 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
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
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
Sponsor or person
Institute
Aizu chuo hospital
Institute
Department
Personal name
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
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® 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® 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003901
