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

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

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.

Study Overview

• Status: Completed
• Conditions: Septicemic Shock
• Intervention / Treatment: Combination product: High SID fluid; Combination product: 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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High SID fluid; Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate	Combination product: High 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.
ACTIVE_COMPARATOR: Hartmann's solution; Group 2: Hartmann's Solution	Combination product: Hartmann's solution; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinical Research Centre, Malaysia
• Investigators: Principal Investigator: Chunchiat Yeoh, MD, Emergency Department, Hospital Pulau Pinang

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): December 18, 2017
• Study Completion (ACTUAL): January 18, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (ACTUAL): May 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 27, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: ED-HPP-1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No