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).

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). - Effect of correction of metabolic acidosis in ARDS patients: A RCT of sodium bicarbonate and THAM.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021756

Enrollment

100

Registered

2016-05-01

Start date

2016-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute respiratory distress syndrome (ARDS)

Interventions

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 dependen

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&lt

pH) 0.2 meq/kg/h = 0.24 ml/kg/hr 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 depend

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&lt

pH) 0.2 meq/kg/h = 0.67 ml/kg/hr

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Minute volume within six hours from start of administration	—

Secondary

Measure	Time frame
pH, PaCO2, blood pressure, and heart rate within six hours from start of administration	—

Countries

Japan

Contacts

Public ContactUchiyama Akinori

Osaka University Hospital intensive care unit

auchiyama@hp-icu.med.osaka-u.ac.jp06-6879-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026