LactateNCT07908056
Evaluate Precision of the Test for Lactate in Capillary Whole Blood Specimens Using the i-STAT CG4+ Cartridge With the i-STAT 1 Analyzer
An observational study of Lactate, run by Abbott Point of Care at 3 sites in United States.
Trial summary
Assess precision of the i-STAT lactate test with the i-STAT CG4+ cartridge on the i-STAT 1 analyzer using two (2) separate capillary blood specimens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lactate
- What is being tested?
- Fingerstick capillary blood draw
- How many people
- 425 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Oct 2026to 30 Oct 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects from the intended use population.
Who may be able to join
- Subject Inclusion Criteria
- Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- ≥ 18 years of age
Who cannot join
- Subject Exclusion Criteria
- 1. Previous enrollment in this study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Keith H Rose, MD, +1 551-996-4149, Keith.Rose@hmhn.org
Penn State Health Milton S. Hershey Medical Center (Hershey)
Hershey, Pennsylvania, 53226
Michael H Creer, MD, +1 717 531-8615, mcreer@hmc.psu.edu
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Jamie Jasti, MD, + 1 414 955-7625, jjasti@mcw.edu
About this study
Official title: Clinical Evaluation of Precision of the Lactate Test for Capillary Whole Blood Specimens Using the i-STAT CG4+ Cartridge With the i-STAT 1 Analyzer
Assess precision of the i-STAT lactate test with the i-STAT CG4+ cartridge on the i-STAT 1 analyzer using two (2) separate capillary blood specimens.
Read the detailed description
The objective of this study is to assess the precision of the i-STAT lactate test using i-STAT CG4+ cartridge on the i-STAT 1 analyzer with two (2) separate capillary specimens for each subject enrolled in the study.
- Conditions
- Lactate
- Being tested
- Fingerstick capillary blood draw
- Keywords
- Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick capillary blood drawDiagnostic test
Fingerstick capillary blood draw
| Study group | Role | What they receive |
|---|---|---|
| Prospectively enrolled subjects | Prospectively enrolled subjects in the intended use population. Receives: Diagnostic Test: Fingerstick capillary blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision across the reportable range for lactate
The primary outcome measure is to assess the precision across the lactate reportable range for the i-STAT lactate test using the i-STAT CG4+ cartridge on the i-STAT 1 analyzer.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start22 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Abbott Point of Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manish Gupta, MS, MBA, Study director, Abbott Point of Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908056
- Sponsor's protocol ID
- CS-2025-0004
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Precision of the Lactate Test for Capillary Whole Blood Specimens Using the i-STAT CG4+ Cartridge With the i-STAT 1 Analyzer
- ClinicalTrials.gov ID
- NCT07908056
- Acronym / sponsor ID
- CS-2025-0004
- Conditions
- Lactate
- Keywords
- Lactate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Abbott Point of CareIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 30 Oct 2026 (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.
Assess precision of the i-STAT lactate test with the i-STAT CG4+ cartridge on the i-STAT 1 analyzer using two (2) separate capillary blood specimens.
Detailed description
The objective of this study is to assess the precision of the i-STAT lactate test using i-STAT CG4+ cartridge on the i-STAT 1 analyzer with two (2) separate capillary specimens for each subject enrolled in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospectively enrolled subjects | – | Diagnostic Test: Fingerstick capillary blood drawProspectively enrolled subjects in the intended use population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from the intended use population.
Key inclusion criteria (3 listed)
- Subject Inclusion Criteria
- Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- ≥ 18 years of age
Key exclusion criteria (2 listed)
- Subject Exclusion Criteria
- 1. Previous enrollment in this study
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 |
|---|---|---|
| Fingerstick capillary blood drawFingerstick capillary blood draw | Diagnostic test | Prospectively enrolled subjects |
Primary outcome
Precision across the reportable range for lactate
Time frame: Through study completion, an average of 1 year
The primary outcome measure is to assess the precision across the lactate reportable range for the i-STAT lactate test using the i-STAT CG4+ cartridge on the i-STAT 1 analyzer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Manish Gupta, MS, MBA study director
Abbott Point of Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactate, run by Abbott Point of Care at 3 sites in United States.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda Gonzalez Aguirre, PhD (+ 1 613-604-8539, miranda.gonzalezaguirre@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision across the reportable range for lactate (time frame: Through study completion, an average of 1 year). 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 Oct 2026.