UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021756 |
|---|---|
| Receipt number | R000025014 |
| Scientific Title | Effect of correction of metabolic acidosis on respiration and hemodynamics in acute respiratory distress syndrome (ARDS) patients during mechanical ventilation: A randomized comparison of sodium bicarbonate and Tris-hydroxymethyl aminomethane (THAM). |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/04/03 11:45:11 |
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Basic information
Public title
Effect of correction of metabolic acidosis on respiration and hemodynamics in acute respiratory distress syndrome (ARDS) patients during mechanical ventilation: A randomized comparison of sodium bicarbonate and Tris-hydroxymethyl aminomethane (THAM).
Acronym
Effect of correction of metabolic acidosis in ARDS patients: A RCT of sodium bicarbonate and THAM.
Scientific Title
Effect of correction of metabolic acidosis on respiration and hemodynamics in acute respiratory distress syndrome (ARDS) patients during mechanical ventilation: A randomized comparison of sodium bicarbonate and Tris-hydroxymethyl aminomethane (THAM).
Scientific Title:Acronym
Effect of correction of metabolic acidosis in ARDS patients: A RCT of sodium bicarbonate and THAM.
Region
| Japan |
Condition
Condition
acute respiratory distress syndrome (ARDS)
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of correction of metabolic acidosis by sodium bicarbonate and tris-hydroxymethyl aminomethane (THAM) on respiration and hemodynamics in ARDS patients with mechanical ventilation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minute volume within six hours from start of administration
Key secondary outcomes
pH, PaCO2, blood pressure, and heart rate within six hours from start of administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sodium bicarbonate group:
Intravenous infusion of 7% sodium bicarbonate (0.833mEq/ml) starting with loading dose (1.8mEq/kg in 30min) and following continuous infusion by administration rate dependent on pH of blood sample as follows: (pH<7.35) 1.0 meq/kg/h = 1.2 ml/kg/hr, (7.35-7.45) 0.5 meq/kg/h = 0.6 ml/kg/hr, (7.45<pH) 0.2 meq/kg/h = 0.24 ml/kg/hr
Interventions/Control_2
THAM group:
Intravenous infusion of THAM (0.3 mmol/ml) starting with loading dose (1.8mEq/kg in 30min) and following continuous infusion by administration rate dependent on pH of blood sample as follows: (pH<7.35) 1.0 mEq/kg/h = 3.33 ml/kg/hr, (7.35-7.45) 0.5 meq/kg/h = 1.67 ml/kg/hr, (7.45<pH) 0.2 meq/kg/h = 0.67 ml/kg/hr
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving mechanical ventilation in ICU of Osaka University Hospital and satisfying following conditions:
1. Patients over 18 years old
2. ARDS patients (mild to severe) who meet the Berlin definition of ARDS
3. BE < -2 in arterial blood sample and needed correction of metabolic acidosis
4. No correction of metabolic acidosis has been done within six hours before
5. Intra-arterial catheter is inserted
6. The written consent for participating this study has been obtained from legal representative
Key exclusion criteria
1. Patients under 18 years old
2. Patients of central nervous system (CNS) diseases with increased intracranial pressure
3. Female patients who are pregnant, lactating and with possibility of pregnant
4. Patients with artificial cardiopulmonary system
5. Other patients who are judged to be inappropriate for this study by research contact person.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uchiyama Akinori |
Organization
Osaka University Hospital
Division name
intensive care unit
Zip code
Address
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL
06-6879-5111
auchiyama@hp-icu.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uchiyama Akinori |
Organization
Osaka University Hospital
Division name
intensive care unit
Zip code
Address
2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL
06-6879-5111
Homepage URL
auchiyama@hp-icu.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2016 | Year | 05 | Month | 01 | 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
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | 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
| 2016 | Year | 04 | Month | 03 | Day |
Last modified on
| 2016 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025014
