Septic ShockNCT04425161
Ratio of ''Central Venous-to-Arterial Co2 Gap'' to ''Arterial-to-Central Venous O2 Content Gap'' in Septic Shock
An observational study of Septic Shock, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fluid challenge (0.9 % NaCl)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients who will be admitted to intensive care units and eligible for the study.
Who may be able to join
- Age >18 years.
- Suspected infection focus
- Mean blood pressure <65 mmHg, or required vasopressor infusion.
- Lactic acid level >2 mmol/l.
- Mechanically ventilated patients.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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%).
- Conditions
- Septic Shock
- Being tested
- Fluid challenge (0.9 % NaCl)
- Keywords
- sepsis, PCO2 gap, PCO2 gap/ O2 content gap
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challenge (0.9 % NaCl)Other
500 ml Fluid challenge of (0.9 % NaCl) will be given
| Study group | Role | What they receive |
|---|---|---|
| VO2 ≥15 % | This group is classified based on increased oxygen consumption (VO2) ≥15 % by volume expansion in fluid responders Receives: 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 Receives: Other: Fluid challenge (0.9 % NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements will be taken immediately before and immediately after volume expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start20 Jul 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atta Ahmed Elsawy, Ain Shams University
- Investigators
- Ahmed A Elsawy, Master, Principal investigator, Ain Shams UniversityAyman M Kamaly, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425161
- Sponsor's protocol ID
- FMASU MD 1322018
- Status last verified
- Aug 2021
- First submitted
- 6 Jun 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04425161
- Acronym / sponsor ID
- FMASU MD 1322018
- Conditions
- Septic Shock
- Keywords
- sepsis, PCO2 gap, PCO2 gap/ O2 content gap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VO2 ≥15 % | – | Other: Fluid challenge (0.9 % NaCl)This group is classified based on increased oxygen consumption (VO2) ≥15 % by volume expansion in fluid responders |
| VO2 <15 % | – | Other: Fluid challenge (0.9 % NaCl)This group is classified based on increased oxygen consumption (VO2) < 15 % by volume expansion in fluid responders |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients who will be admitted to intensive care units and eligible for the study.
Key inclusion criteria (5 listed)
- Age >18 years.
- Suspected infection focus
- Mean blood pressure <65 mmHg, or required vasopressor infusion.
- Lactic acid level >2 mmol/l.
- Mechanically ventilated patients.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challenge (0.9 % NaCl)500 ml Fluid challenge of (0.9 % NaCl) will be given | Other | VO2 <15 %, VO2 ≥15 % |
Primary outcome
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.
Time frame: Measurements will be taken immediately before and immediately after volume expansion
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed A Elsawy, Master principal investigator
Ain Shams University
Ayman M Kamaly, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Measurements will be taken immediately before and immediately after volume expansion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.