Septicemic ShockHiSIDSSNCT03530046
High Strong Ion Difference Fluid vs Hartmann's Solution on Acid-Base Status in Sepsis
A study testing High SID fluid and Hartmann's solution in people with Septicemic Shock, run by Clinical Research Centre, Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septicemic Shock
- What is being tested?
- High SID fluid and Hartmann's solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 18 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years
- fulfills 2/3 qSOFA criteria
- presumed infection
- a blood pH at presentation ≤ 7.35
- hyperlactatemia (blood lactate level, >2mmol/L )
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Septicemic Shock
- Being tested
- High SID fluid, Hartmann's solution
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High SID fluidCombination product
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 solutionCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| High SID fluid | Experimental | Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate Receives: Combination Product: High SID fluid |
| Hartmann's solution | Active comparator | Group 2: Hartmann's Solution Receives: Combination Product: Hartmann's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH change
Measured: 2 hours
bicarbonate level change
mmol/L
Measured: 2 hours
Secondary outcomes (4)
Lactate level difference
percentage
Measured: 2 hours
Development of pulmonary edema
Measured: 48 hours
30 days all-cause mortality
Measured: 30 days
Length of stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jan 2017
- Primary completion18 Dec 2017
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septicemic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeoh Chun Chiat, Clinical Research Centre, Malaysia
- Investigators
- Chunchiat Yeoh, MD, Principal investigator, Emergency Department, Hospital Pulau Pinang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530046
- Sponsor's protocol ID
- ED-HPP-1701
- Acronym
- HiSIDSS
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03530046
- Acronym / sponsor ID
- HiSIDSS / ED-HPP-1701
- Conditions
- Septicemic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High SID fluid | Experimental | Combination Product: High SID fluidGroup 1: half-normal saline with addition of 75mEq/L sodium bicarbonate |
| Hartmann's solution | Active comparator | Combination Product: Hartmann's solutionGroup 2: Hartmann's Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age≥18 years
- fulfills 2/3 qSOFA criteria
- presumed infection
- a blood pH at presentation ≤ 7.35
- hyperlactatemia (blood lactate level, >2mmol/L )
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High SID fluidThe 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 product | High SID fluid |
| Hartmann's solutionThe 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 product | Hartmann's solution |
Primary outcome
pH change
Time frame: 2 hours
bicarbonate level change
Time frame: 2 hours
mmol/L
4 secondary outcomes
Lactate level difference
Time frame: 2 hours
Development of pulmonary edema
Time frame: 48 hours
30 days all-cause mortality
Time frame: 30 days
Length of stay
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: No
Related trials for Septicemic Shock
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Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunchiat Yeoh, MD principal investigator
Emergency Department, Hospital Pulau Pinang
Questions about this trial
What is this clinical trial studying?
A study testing High SID fluid and Hartmann's solution in people with Septicemic Shock, run by Clinical Research Centre, Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pH change (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.