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

Septicemic Shock Clinical Trial

— HiSIDSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530046
• Other study ID #: ED-HPP-1701
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 18, 2018

Study information

• Verified date: May 2018
• Source: Clinical Research Centre, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 18, 2018
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septicemic Shock
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH change		2 hours
Primary	bicarbonate level change	mmol/L	2 hours
Secondary	Lactate level difference	percentage	2 hours
Secondary	Development of pulmonary edema		48 hours
Secondary	30 days all-cause mortality		30 days
Secondary	Length of stay		90 days