- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07799727
Central Venous vs Arterial Blood Gas and CO2 Gap in Critically Ill Patients With and Without Diabetes
Correlation Between Central Venous and Arterial Blood Gas Parameters Including CO2 Gap in Diabetic and Non-Diabetic Critically Ill Patients
Frequent monitoring of acid-base status, ventilation, and tissue oxygenation is essential for managing critically ill patients in the intensive care unit (ICU). While arterial blood gas (ABG) analysis is considered the standard method for these evaluations, maintaining arterial catheters carries risks of complications, such as thrombosis, hematoma, and infection. Central venous blood gas (CVBG) analysis offers a safer alternative because central venous catheters are already routinely placed for patient care. Additionally, the venous-to-arterial carbon dioxide difference (CO2 gap) serves as an indicator of systemic blood flow and tissue perfusion.
However, patients with diabetes mellitus often present with underlying microvascular alterations, endothelial changes, and metabolic variations that might alter tissue perfusion and peripheral gas exchange. This study aims to assess the correlation and agreement between central venous and arterial blood gas parameters, as well as evaluate the diagnostic accuracy of the CO2 gap, in diabetic versus non-diabetic critically ill patients.
A total of 100 adult ICU patients (50 diabetic and 50 non-diabetic) with pre-existing central venous and arterial lines will be enrolled. Paired blood samples will be drawn simultaneously to compare blood gas values and calculate the CO2 gap without altering standard clinical treatment.
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Critically ill patients admitted to the intensive care unit (ICU)
- Patients with indwelling central venous catheter and arterial line placed for routine clinical management
- Written informed consent obtained from the patient or legal next of kin
Exclusion Criteria:
- Known severe peripheral vascular occlusive disease affecting line placement
- Use of a pulmonary artery catheter (mixed venous blood line) instead of a standard central venous catheter positioned at the superior/inferior vena cava junction
- Refusal of the patient or legal representative to participate in the study
- Patients younger than 18 years of age
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Diabetic Critically Ill Patients
Critically ill adult patients admitted to the intensive care unit who have a confirmed diagnosis of Diabetes Mellitus.
All participants undergo simultaneous paired arterial and central venous blood gas sampling to evaluate agreement and CO2 gap dynamics.
|
|
Non-Diabetic Critically Ill Patients
Critically ill adult patients admitted to the intensive care unit without a history or diagnosis of Diabetes Mellitus.
All participants undergo simultaneous paired arterial and central venous blood gas sampling to evaluate agreement and CO2 gap dynamics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Venous-to-Arterial Carbon Dioxide Tension Difference (Delta PCO2)
Time Frame: Baseline
|
Delta PCO2 (CO2 gap) is calculated as central venous PCO2 minus arterial PCO2 (PvCO2 - PaCO2) measured in mmHg.
Paired arterial and central venous blood gas samples are collected simultaneously and analyzed within 10 minutes.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVBG vs ABG in ICU Diabetics
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