High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang

Conditions
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Septicemic Shock

Intervention / Treatment
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* Combination Product: High SID fluid
* Combination Product: Hartmann's solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥18 years fulfills 2/3 qSOFA criteria presumed infection a blood pH at presentation ≤ 7.35 hyperlactatemia (blood lactate level, >2mmol/L ) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High SID fluid<br>Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate | Combination Product: High SID fluid<br>* The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.<br>|
| Active Comparator: Hartmann's solution<br>Group 2: Hartmann's Solution | Combination Product: Hartmann's solution<br>* The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH change |  | 2 hours | 
| bicarbonate level change | mmol/L | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate level difference | percentage | 2 hours | 
| Development of pulmonary edema |  | 48 hours | 
| 30 days all-cause mortality |  | 30 days | 
| Length of stay |  | 90 days |