Clinical trial NCT04425161: Ratio of ''Central Venous-to-Arterial Co2 Gap'' to ''Arterial-to-Central Venous O2 Content Gap'' in Septic Shock
Official title: Role of "Central Venous-to-Arterial Carbon Dioxide" to "Arterial-to-Central Venous Oxygen Content" Ratio, as a Marker of Anaerobic Metabolism in Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: sepsis
PCO2 gap
PCO2 gap/ O2 content gap
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients who will be admitted to intensive care units and eligible for the study.

Brief summary: The high ratio of "central venous to arterial carbon dioxide" to "arterial to central venous oxygen content " is associated with elevated lactate in patients with septic shock.

So, the aim of the present study is to evaluate the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-venous O2 content'' as an indicator of anaerobic metabolism in septic shock.

Detailed description: This is a prospective single center observational study that will be conducted in adult intensive care unit of Ain Shams University After being approved by local institutional ethic committee (Ain Shams University, Egypt). Informed consent was obtained from each participant's next of kin. The investigator will study mechanically ventilated participants. the attending physician's decision is to give IV fluids to participants due to the presence of at least one clinical sign of inadequate tissue perfusion due to septic shock : (a) systolic arterial pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or the need for vasopressor infusion; (b) skin mottling; (c) lactate level \>2 mmo/L; or (d) urinary output \<0.5 mL/kg/h for ≥2 h. Jugular central venous and arterial catheters will be in place by the attending physician. Investigator will confirm the position of the tip of the central venous catheter in the superior vena cava or upper part of the right atrium on chest radiograph. Participants will be monitored by Flo Trac device as a part of routine management in local ICU.

A first set of measurements will be performed, including hemodynamic and tissue oxygenation variables (heart rate, mean arterial pressure, cardiac index (CI), oxygen delivery (DO2), oxygen consumption (VO2), Central venous oxygen saturation (ScvO2), arterial lactic acid level, central venous to arterial carbon dioxide tension difference (∆PCO2), central venous to arterial CO2 content difference (∆ContCO2), arterial-to-central venous oxygen content difference (∆ContO2), ∆ContCO2/∆ContO2 ratio and ∆PCO2/∆ContO2 ratio. 500 ml of isotonic saline 0.9% will be infused to the participants via a specific venous line over 15 minutes. Immediately after volume expansion, a second set of the previous measurements will be recorded. Ventilation parameters, Norepinephrine dose and sedation drugs will be kept constant during the fluid challenge.

After fluid challenge, Participants with an increase in cardiac index ≥15% will be defined as fluid responders. Fluid responders will be divided into 2 groups based on increase in oxygen consumption (VO2) ( \< or ≥15%).

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years.
2. Suspected infection focus
3. Mean blood pressure \<65 mmHg, or required vasopressor infusion.
4. Lactic acid level \>2 mmol/l.
5. Mechanically ventilated patients.

Exclusion Criteria:

1. Age equal or less than 18 years.
2. Pregnant women.
3. Liver cirrhosis Child-Pugh C.
4. Chronic obstructive pulmonary disease.
5. Previous episode of septic shock within the last 3 months.
6. Patients with a contraindication to volume expansion.

Primary outcomes:
measure: Evaluation of the change of the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-central venous O2 content" as an effective marker to indicate anaerobic metabolism in septic shock.
timeFrame: Measurements will be taken immediately before and immediately after volume expansion
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams
Study officials:
affiliation: Ain Shams University
name: Ahmed A Elsawy, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Ayman M Kamaly, Professor
role: STUDY_DIRECTOR
References: