NCT07799727

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

August 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 30, 2026

Last Update Submit

August 30, 2026

Conditions

Keywords

Central Venous Blood GasArterial Blood GasCO2 GapVenous-to-arterial PCO2 DifferenceIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Venous-to-Arterial Carbon Dioxide Tension Difference (Delta PCO2)

    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

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult critically ill patients (both diabetic and non-diabetic) admitted to the Critical Care Unit of the Internal Medicine Department at Assiut University Hospital who have standard clinical indications for indwelling central venous catheters and arterial lines.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical IllnessDiabetes MellitusAcid-Base Imbalance

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Internal Medicine

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 2, 2026

Record last verified: 2026-08