UMIN-CTR Clinical Trial

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

acute respiratory distress syndrome (ARDS)

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

auchiyama@hp-icu.med.osaka-u.ac.jp

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

Email

auchiyama@hp-icu.med.osaka-u.ac.jp

Institute

Osaka University Hospital

Institute

Department

Personal name

Organization

nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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