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
1 other identifier
interventional
162
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedMay 30, 2018
May 1, 2018
12 months
May 8, 2018
May 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
pH change
2 hours
bicarbonate level change
mmol/L
2 hours
Secondary Outcomes (4)
Lactate level difference
2 hours
Development of pulmonary edema
48 hours
30 days all-cause mortality
30 days
Length of stay
90 days
Study Arms (2)
High SID fluid
EXPERIMENTALGroup 1: half-normal saline with addition of 75mEq/L sodium bicarbonate
Hartmann's solution
ACTIVE COMPARATORGroup 2: Hartmann's Solution
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- age≥18 years
- fulfills 2/3 qSOFA criteria
- presumed infection
- a blood pH at presentation ≤ 7.35
- hyperlactatemia (blood lactate level, \>2mmol/L )
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunchiat Yeoh, MD
Emergency Department, Hospital Pulau Pinang
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 21, 2018
Study Start
January 1, 2017
Primary Completion
December 18, 2017
Study Completion
January 18, 2018
Last Updated
May 30, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share