CO2 Gap Changes in Septic Shock in Relation to Cardiac Output

NCT05578534 | Completed

• 1 other identifier: MD-194-2019
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Background The arteriovenous difference of partial pressure of carbon dioxide (PCO2) between mixed or central venous blood and arterial blood is the ∆PCO2 or CO2 gap. Previous data demonstrated a strong relationship between ∆PCO2 and cardiac index (CI) at the very early phase of resuscitation in septic shock. Monitoring the ∆PCO2 from the beginning of the resuscitation may be a useful tool to assess the adequacy of cardiac output (CO) in tissue perfusion. Aim of work: To examine behavior of ∆PCO2 during early management of septic shock. Methodology: Seventy-six patients with diagnosis of septic shock admitted to critical care department, Cairo university hospitals. We classified the study population according to initial resuscitation response, initial CO2 gap, or 28-days mortality. The response vs non-response to initial resuscitation, ICU morbidity and recovery rate were the study primary outcomes while secondary outcomes included ICU length of stay (LOS) and 28-day ICU Mortality.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• The response to initial resuscitation

  response to intial resuscitation with IV fluids and vasopressors measured by PCO2 gap

  6 hours

Secondary Outcomes (1)

• ICU length of stay (LOS) and 28-day mortality

  28 days

Study Arms (6)

High CO2 gap (Pcv-aCO2 > 6 mmHg)

Patients had high PCO2 gaps before initial resuscitation

Normal CO2 gap (Pcv-aCO2 ≤6 mmHg)

Patients had normal PCO2 gaps before initial resuscitation

Responsive (15% increase in CI or stable MAP was achieved)

Patients who respond to initial resuscitation with 15% increase in CI

Non-responsive (< 15% increase in CI or a stable MAP was not achieved)

Patients who do not respond to initial resuscitation with less than 15% increase in CI

Survivors

Patients who survived after 28 days

Non survivors

Patients who do not survive within 28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

76 consecutive adult patients admitted to critical care department of Cairo university hospitals with septic shock

You may qualify if:

• adult patients admitted to critical care department of Cairo university hospitals with septic shock and elevated blood lactate level \> 2 mmol/ L requiring fluid resuscitation and/ or vasopressor drugs infusion.

You may not qualify if:

• Patients with advanced cardiac, pulmonary, hepatic, or renal diseases were excluded from enrolment.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Critical care department

Cairo, 12358, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Farouk Faris, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of critical care

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 13, 2022
• Study Start: December 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: October 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

EG (1)