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

Clinical Research Centre, Malaysia

Status: Completed

Conditions: Septicemic Shock

Treatments: Combination Product: High SID fluid; Combination Product: Hartmann's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03530046

ED-HPP-1701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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162 participants in 2 patient groups

High SID fluid

Experimental group

Description:

Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate

Treatment:

Combination Product: High SID fluid

Hartmann's solution

Active Comparator group

Description:

Group 2: Hartmann's Solution

Treatment:

Combination Product: Hartmann's solution