Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Septic Shock
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

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 invest...

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%).

Tracking Information

NCT #
NCT04425161
Collaborators
Not Provided
Investigators
Principal Investigator: Ahmed A Elsawy, Master Ain Shams University Study Director: Ayman M Kamaly, Professor Ain Shams University