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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03530046

Acronym

HiSIDSS

Enrollment

162

Registered

2018-05-21

Start date

2017-01-01

Completion date

2018-01-18

Last updated

2018-05-30

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

Conditions

Septicemic Shock

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.

Interventions

COMBINATION_PRODUCTHigh SID fluid

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.

COMBINATION_PRODUCTHartmann's solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
pH change	2 hours	—
bicarbonate level change	2 hours	mmol/L

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026