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A Proof of Concept Research on sodium bicarbonate treatment for the patients with acute traumatic brain injury

A Proof of Self-control Concept Research on sodium bicarbonate treatment for the patients with spontaneous hyperventilation secondary to acute traumatic brain injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040669
Enrollment
Unknown
Registered
2020-12-07
Start date
2020-12-03
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

traumatic brain injury

Interventions

Case series:sodium bicarbonate

Sponsors

Department of neurosurgery, Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 75 years old, on matter male or female; 2. The patients would be stable with acute traumatic brain injury diagnosed by CT scan within 3-7 days after onset, having undergone surgical treatment or not; 3. The GCS of the patients would range from 5 to 12 scores, with severe simple hypocapnia, PaCO2 7.45; 4. No acute or chronic renal failure, chronic cardiopulmonary disease, chronic liver disease, chronic kidney disease, blood disease, etc; 5. Patients with indications of lumbar puncture examination; 6. Patients without other serious injuries.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable vital signs or with acute or chronic heart, kidney and digestive tract dysfunction; 2. Non simple hypocapnia, such with metabolic acidosis or metabolic alkalosis indicated by arterial blood gas; or mild hypocapnia with PaCO2 >=30mmhg; 3. Patients who had been treated with sodium bicarbonate within 24 hours before this screening; 4. Patients with history of asthma, mental disorders, iatrogenic hyperventilation therapy; patients with previous history of chronic cardiopulmonary disease, malignant arrhythmia, chronic liver disease, chronic kidney disease, blood disease, severe metabolic abnormalities, malignant tumor, etc; 5. GCS 12; 6. Patients who need further surgical treatment; 7. Patients with contraindication or failure of lumbar puncture could not obtain CSF; 8. They had a history of craniotomy, cerebral infarction, cerebral hemorrhage and other neurological dysfunction or chronic nerve injury, neurological function or mental disorder; 9. Pregnant patients; 10. Patients with unknown medical history before admission; 11. Serious electrolyte disorders that could not be corrected included blood sodium >155 mmol/L, blood potassium <3 mmol/L, blood calcium < 1.8 mmol/L or free calcium < 0.9 mmol/L; 12. There are other serious life-threatening diseases or injuries, such as severe chest and abdominal trauma.

Design outcomes

Primary

MeasureTime frame
change of motor scores between the 14th day and baseline;

Secondary

MeasureTime frame
change of arterial blood gas analysis;change of CSF gas analysis;change of cerebral blood flow after the intervention;change of EEG after the intervention;GOSE at 28th day;

Countries

China

Contacts

Public ContactJiang Rongcai

Department of neurosurgery, Tianjin Medical University General Hospital

jiang116216@163.com+86 13672116556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026