Ratio of ''Central Venous-to-Arterial Co2 Gap'' to ''Arterial-to-Central Venous O2 Content Gap'' in Septic Shock

NCT04425161 | Unknown DMC

• 1 other identifier: FMASU MD 1322018
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

sepsis; PCO2 gap; PCO2 gap/ O2 content gap

Outcome Measures

Primary Outcomes (1)

• 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.

  To evaluate the change of the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-central venous O2 content" between immediately before and Immedialey after volume expansion to indicate anaerobic metabolism in septic shock.

  Measurements will be taken immediately before and immediately after volume expansion

Study Arms (2)

VO2 ≥15 %

This group is classified based on increased oxygen consumption (VO2) ≥15 % by volume expansion in fluid responders

Other: Fluid challenge (0.9 % NaCl)

VO2 <15 %

This group is classified based on increased oxygen consumption (VO2) \< 15 % by volume expansion in fluid responders

Other: Fluid challenge (0.9 % NaCl)

Interventions

Fluid challenge (0.9 % NaCl) OTHER

500 ml Fluid challenge of (0.9 % NaCl) will be given

VO2 <15 %; VO2 ≥15 %

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients who will be admitted to intensive care units and eligible for the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams

Cairo, Egypt

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed A Elsawy, Master

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ayman M Kamaly, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: July 20, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

EG (1)