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Physiologic pH Low Chloride Balanced-Salt Solution Versus Lactate Ringer Solution for Resuscitation in Traumatic Patients: A Double- blind Randomized Controlled Feasibility study

Physiologic pH Low Chloride Balanced-Salt Solution Versus Lactate Ringer Solution for Resuscitation in Traumatic Patients: A Double- blind Randomized Controlled Feasibility study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250903003
Enrollment
52
Registered
2025-09-03
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Metabolic acidosis in traumatic patient with hemorrhagic shock Trauma, Hemorrhagic shock, Lactate Ringer&#039

Interventions

Balanced salt solution as standard treatment,We use TOP balance solution, produced by Thai Otsuka pharmaceutical, Resemble the Plasmalyte-A solution which is Physiologic pH Low chloride balanced-salt
Active Comparator Drug,Experimental Drug
Lactate ringer&#039
s solution,Physiologic pH Low chloride balanced-salt solution

Sponsors

Department of surgery, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Systolic blood pressure less than 90 mmHg or with sign of shock 2. Patient with blood lactate > 4 mmol/L or base excess < -2 3. Need immediate or emergency surgery within 120 minutes after arrival 4. Need for intubation due to severe metabolic acidosis 5. Need for blood transfusion or massive blood transfusion, defined by hemorrhagic shock grade 3 or 4

Exclusion criteria

Exclusion criteria: 1. Patient age < 20 or > 60 years old 2. Patient who not expected to survive to 72 hours 3. Moderate to severe head injury (Glasgow Coma Score <= 12) or evidence of intracranial hemorrhage 4. Pregnancy 5. Patient with documented chronic kidney disease; GFR <= 30 6. Patient who treated with or scheduled to have renal replacement therapy (including peritoneal dialysis and hemodialysis) 7. Patient with kidney transplantation 8. Cannot obtain consent form after intervention 9. Patient with chronic liver disease (Child-Pugh score>7) 10. Patient with documented or suspected of heart disease, congestive heart failure, pulmonary edema 11. Patient who is previously treated with lithium* which is contraindicated for studied fluid administration 12. Patient who at risk of hyperkalemia, including patients with severe renal impairment 13. Patients with or predisposed to hypermagnesemia, including patients with severe renal impairment and those patients receiving magnesium therapy (e.g., treatment of eclampsia and myasthenia gravis). 14. Patient with cardiac arrest either pre-hospital or upon arrival. 15. Patient who undergoes emergency thoracotomy

Design outcomes

Primary

MeasureTime frame
Time to normalize base excess 72 hours after resuscitation Base excess

Secondary

MeasureTime frame
Incidence of electrolytes imbalance 72 hours post resuscitation blood test,incidence of adverse renal events 72 hour after resuscitation blood test ,Liver function test 72 hours post resuscitation blood test ,length of hospital and ICU stay, mortality rate in 30 days 30 days medical record,coagulopathy 72 hours after resuscitation blood test

Countries

Thailand

Contacts

Public ContactPratchaya Wisutthithada

Chiangmai university

pratchaya.w@cmu.ac.th0876107090

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026