High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
- Conditions
- Septicemic Shock
- Registration Number
- NCT03530046
- Lead Sponsor
- Clinical Research Centre, Malaysia
- Brief Summary
This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.
- Detailed Description
Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies.
The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level.
High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- age≥18 years
- fulfills 2/3 qSOFA criteria
- presumed infection
- a blood pH at presentation ≤ 7.35
- hyperlactatemia (blood lactate level, >2mmol/L )
- existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
- known pregnancy
- suspected dengue
- primary diagnosis is related to burn, trauma, or drug overdose
- if more than 500cc of resuscitation fluid was administered before enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method bicarbonate level change 2 hours mmol/L
pH change 2 hours
- Secondary Outcome Measures
Name Time Method Lactate level difference 2 hours percentage
Development of pulmonary edema 48 hours Length of stay 90 days 30 days all-cause mortality 30 days