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

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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 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


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

Value
https://center6.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