UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012581 |
|---|---|
| Receipt number | R000010989 |
| Scientific Title | blood lactate level as an indicator of low output syndrome in patients with heart failure |
| Date of disclosure of the study information | 2013/12/15 |
| Last modified on | 2013/12/15 15:25:00 |
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Basic information
Public title
blood lactate level as an indicator of low output syndrome in patients with heart failure
Acronym
low output syndrome and lactate
Scientific Title
blood lactate level as an indicator of low output syndrome in patients with heart failure
Scientific Title:Acronym
low output syndrome and lactate
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether blood lactate level has predictive value for detecting low output syndrome in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between blood lactate level and hemodynamic parameters obtained by pulmonary artery catheter
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients who required single spot pulmonary artery catheter (Swan-Ganz catheter) study during treatment
Key exclusion criteria
The patients who had active infectious disease or arterio-venous shunt
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Iida |
Organization
Nihon University Surugadai Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
kiida2830@jcom.home.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Iida |
Organization
Nihon University Surugadai Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-13 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
03-3293-1711
Homepage URL
kiida2830@jcom.home.ne.jp
Sponsor or person
Institute
Nihon University Surugadai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
駿河台日本大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We conducted a research study to clarify whether blood lactate level has a predictive value for detecting LOS in patients with heart failure (HF) (n=32) who required single spot pulmonary artery catheter(PAC) study during treatment (average age; 66years, male; 69%). Blood lactate level showed significant correlations between stroke volume index and cardiac index (r=-0.49 p<0.01, r=-0.66 p<0.001, respectively). When the cut-off point of blood lactate level was 10 mg/dl, the sensitivity (88%) + specificity (96%) of the test was maximal, and the accuracy was 94% for the identification of low CI (below 2.2).
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
| 2012 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Lactate is an excellent marker for detecting LOS in patients with HF. This result may provide useful information regarding cardiac output immediately at the bedside without performing PAC.
Management information
Registered date
| 2013 | Year | 12 | Month | 15 | Day |
Last modified on
| 2013 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010989
