UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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).
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Uchiyama Akinori
Organization	Osaka University Hospital
Division name	intensive care unit
Address	2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL	06-6879-5111
Email	auchiyama@hp-icu.med.osaka-u.ac.jp

Public contact
Name of contact person	Uchiyama Akinori
Organization	Osaka University Hospital
Division name	intensive care unit
Address	2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL	06-6879-5111
Homepage URL
Email	auchiyama@hp-icu.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025014