Septic ShockNCT06119815
CO2 Gap Changes Versus Inferior Vena Cava Collapsibility in Relation to Cardiac Index as a Prognostic Value in Septic Shock
A study testing CO2 GAP in people with Septic Shock, run by Sohag University at 1 site in Egypt.
Trial summary
In 2016, sepsis and septic shock was redocumented as fatal organ dysfunction caused by infection-induced host response disorders (Singer et al. 2016). Infectious shock is a subtype of sepsis; its circulation abnormalities significantly increase the mortality rate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- CO2 GAP
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 10 Oct 2025
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- o Patients with a diagnosis of severe septic shock.
- Patients With an ICU stay of more than 24 hours
Who cannot join
- o Age <18 years old.
- Patients with (COPD).
- Patients with heart failure.
- Patients with active pulmonary edema
Trial locations and contacts
1 site in 1 country.
alhadad a ali, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
magdy m Amin, Professor
About this study
Official title: co2 Gap Changes Versus Inferior Vena Cava Collapsibility in Relation to Cardiac Index as a Prognostic Value in Septic Shock
In 2016, sepsis and septic shock was redocumented as fatal organ dysfunction caused by infection-induced host response disorders (Singer et al. 2016). Infectious shock is a subtype of sepsis; its circulation abnormalities significantly increase the mortality rate. The definition was updated to facilitate rapid identification and timely treatment. Despite the continuous progress of awareness and intervention, the mortality rate of septic shock is approaching 40% or more (Gasim et al. 2016, Karampela et al. 2022).
Infectious shock exists in the presence of imbalance of oxygen supply and demand as well as tissue hypoxia, early improvement of tissue hypoperfusion is key to the treatment, a specific cluster treatment program was recommended in the guidelines of sepsis rescue action (Rhodes et al. 2017).
Read more
Severe sepsis remains associated with high mortality, and the early recognition of the signs of tissue hypoperfusion is crucial in its management. The effectiveness of oxygen-derived parameters as resuscitation goals has been questioned, and the latest data have failed to demonstrate clinical advantage (Rudd et al. 2020).
Prompt diagnosis and appropriate treatment of sepsis are of ulmost importance and key to survival. However, routinely used biomarkers, such as C-reactive protein and procalcitonin, have shown moderate diagnostic and prognostic value. Of note, the recent consensus definition for sepsis is based on clinical criteria, implying the paucity of reliable sepsis biomarkers. The new diagnostic criteria also incorporate the use of the SOFA score, a composite prediction tool, which is derived by a combination of clinical signs and biomarkers of organ dysfunction, leaving aside classic inflammatory biomarkers (Pierrakos et al. 2020, Karampela et al. 2022).
The venous oxygen saturation (SvO2) is <70% in the majority of patients with severe sepsis on admission to the intensive care unit (ICU). The central venous-to-arterial carbon dioxide difference or only carbon dioxide gap (PCO2 gap) has gained relevance as a measure of assessment of several parameters (Mallat et al. 2015). The balance of dioxide carbon (CO2) production by the tissues and its elimination through the lungs can be reflected by the difference between the mixed venous content (CvCO2) and the arterial content (CaCO2). This venous-arterial difference in CO2 content (CCO2) can be estimated by the following equation: ΔPCO2 = PvCO2 - PaCO2, denominated PCO2 gap and in physiological conditions it ranges from 2 to 5 mmHg. In a few words, it indicates the difference between partial pressure of carbon dioxide in central venous blood (PvCO2) and arterial blood (PaCO2) (Janotka et al. 2021). The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis (Ospina-Tascon et al. 2016, de Sá 2022).
Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen derived parameters during the early phases of resuscitation in septic shock. The PCO2 gap can be a marker of cardiac output adequacy in global metabolic conditions that are less affected by the impairment of oxygen extraction capacity (Bitar et al. 2020).
- Conditions
- Septic Shock
- Being tested
- CO2 GAP
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 GAPDiagnostic test
Also called IVC collapsibility, echocardiology
CO2 gap will be measured by insertion of radial arterial cannula and internal jugular C.V.P
- I.V.C collapsibility will be measured by abdominal us at the subcostal area and the IVC diameters will be measured in M-mode coupled to 2D mode 3 cm before the IVC joined the right atrium to ensure that IVC diameter measurements are accurate and that the inter- and intra-observer variability of IVC can be minimized. The IVC collapsibility index (IVCCI) will be calculated as follows: (maximum diameter on expiration (IVC max) - minimum diameter on inspiration (IVC min).
- Echocardiography for all patients to asses cardiac index in a parasternal (2D) view. The aortic diameter (AoD) will be measured at the aortic valve annulus. The aortic area (AA) will be calculated using the formula: AA = π × (AoD2/ 4). We measured the aortic blood flow using pulsed
What is being measured
The primary outcome is the main question the study is designed to answer.
co2 Gap changes
CO2 gap will be measured by insertion of radial arterial cannula and internal jugular C.V.P 2
Measured: 24 months
IVC collapsibility
I.V.C collapsibility will be measured by abdominal us at the subcostal area and the IVC diameters will be measured in M-mode coupled to 2D mode 3 cm before the IVC joined the right atrium to ensure that IVC diameter measurements are accurate and that the inter- and intra-observer variability of IVC can be minimized. The IVC collapsibility index (IVCCI) will be calculated as follows: (maximum diameter on expiration (IVC max) - minimum diameter on inspiration (IVC min).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start10 Oct 2023
- Primary completion10 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Ahmed Ragab, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119815
- Sponsor's protocol ID
- soh-Med-23-10-03MD
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bakker J, Vincent JL, Gris P, Leon M, Coffernils M, Kahn RJ. Veno-arterial carbon dioxide gradient in human septic shock. Chest. 1992 Feb;101(2):509-15. doi: 10.1378/chest.101.2.509.
PubMed 1735281Bitar ZI, Maadarani OS, El-Shably AM, Elshabasy RD, Zaalouk TM. The Forgotten Hemodynamic (PCO2 Gap) in Severe Sepsis. Crit Care Res Pract. 2020 Jan 7;2020:9281623. doi: 10.1155/2020/9281623. eCollection 2020.
PubMed 32377433Blanco P, Aguiar FM, Blaivas M. Rapid Ultrasound in Shock (RUSH) Velocity-Time Integral: A Proposal to Expand the RUSH Protocol. J Ultrasound Med. 2015 Sep;34(9):1691-700. doi: 10.7863/ultra.15.14.08059. Epub 2015 Aug 17.
PubMed 26283755Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
PubMed 1303622
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- co2 Gap Changes Versus Inferior Vena Cava Collapsibility in Relation to Cardiac Index as a Prognostic Value in Septic Shock
- ClinicalTrials.gov ID
- NCT06119815
- Acronym / sponsor ID
- soh-Med-23-10-03MD
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
In 2016, sepsis and septic shock was redocumented as fatal organ dysfunction caused by infection-induced host response disorders (Singer et al. 2016). Infectious shock is a subtype of sepsis; its circulation abnormalities significantly increase the mortality rate. The definition was updated to facilitate rapid identification and timely treatment. Despite the continuous progress of awareness and intervention, the mortality rate of septic shock is approaching 40% or more (Gasim et al. 2016, Karampela et al. 2022).
Infectious shock exists in the presence of imbalance of oxygen supply and demand as well as tissue hypoxia, early improvement of tissue hypoperfusion is key to the treatment, a specific cluster treatment program was recommended in the guidelines of sepsis rescue action (Rhodes et al. 2017).
Severe sepsis remains associated with high mortality, and the early recognition of the signs of tissue hypoperfusion is crucial in its management. The effectiveness of oxygen-derived parameters as resuscitation goals has been questioned, and the latest data have failed to demonstrate clinical advantage (Rudd et al. 2020).
Prompt diagnosis and appropriate treatment of sepsis are of ulmost importance and key to survival. However, routinely used biomarkers, such as C-reactive protein and procalcitonin, have shown moderate diagnostic and prognostic value. Of note, the recent consensus definition for sepsis is based on clinical criteria, implying the paucity of reliable sepsis biomarkers. The new diagnostic criteria also incorporate the use of the SOFA score, a composite prediction tool, which is derived by a combination of clinical signs and biomarkers of organ dysfunction, leaving aside classic inflammatory biomarkers (Pierrakos et al. 2020, Karampela et al. 2022).
The venous oxygen saturation (SvO2) is <70% in the majority of patients with severe sepsis on admission to the intensive care unit (ICU). The central venous-to-arterial carbon dioxide difference or only carbon dioxide gap (PCO2 gap) has gained relevance as a measure of assessment of several parameters (Mallat et al. 2015). The balance of dioxide carbon (CO2) production by the tissues and its elimination through the lungs can be reflected by the difference between the mixed venous content (CvCO2) and the arterial content (CaCO2). This venous-arterial difference in CO2 content (CCO2) can be estimated by the following equation: ΔPCO2 = PvCO2 - PaCO2, denominated PCO2 gap and in physiological conditions it ranges from 2 to 5 mmHg. In a few words, it indicates the difference between partial pressure of carbon dioxide in central venous blood (PvCO2) and arterial blood (PaCO2) (Janotka et al. 2021). The venous-to-arterial carbon dioxide difference (Pv-aCO2) can indicate the adequacy of microvascular blood flow in the early phases of resuscitation in sepsis (Ospina-Tascon et al. 2016, de Sá 2022).
Hence, other resuscitation goals, such as PCO2 gap, have been suggested, due to their ability to predict adverse clinical outcomes and simplicity in patients achieving normal oxygen derived parameters during the early phases of resuscitation in septic shock. The PCO2 gap can be a marker of cardiac output adequacy in global metabolic conditions that are less affected by the impairment of oxygen extraction capacity (Bitar et al. 2020).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- o Patients with a diagnosis of severe septic shock.
Key exclusion criteria (4 listed)
- o Age <18 years old.
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 |
|---|---|---|
| CO2 GAPAlso: IVC collapsibility, echocardiologyCO2 gap will be measured by insertion of radial arterial cannula and internal jugular C.V.P * I.V.C collapsibility will be measured by abdominal us at the subcostal area and the IVC diameters will be measured in M-mode coupled to 2D mode 3 cm before the IVC joined the right atrium to ensure that IVC diameter measurements are accurate and that the inter- and intra-observer variability of IVC can be minimized. The IVC collapsibility index (IVCCI) will be calculated as follows: (maximum diameter on expiration (IVC max) - minimum diameter on inspiration (IVC min). * Echocardiography for all patients to asses cardiac index in a parasternal (2D) view. The aortic diameter (AoD) will be measured at the aortic valve annulus. The aortic area (AA) will be calculated using the formula: AA = π × (AoD2/ 4). We measured the aortic blood flow using pulsed | Diagnostic test | – |
Primary outcome
co2 Gap changes
Time frame: 24 months
CO2 gap will be measured by insertion of radial arterial cannula and internal jugular C.V.P 2
IVC collapsibility
Time frame: 24 months
I.V.C collapsibility will be measured by abdominal us at the subcostal area and the IVC diameters will be measured in M-mode coupled to 2D mode 3 cm before the IVC joined the right atrium to ensure that IVC diameter measurements are accurate and that the inter- and intra-observer variability of IVC can be minimized. The IVC collapsibility index (IVCCI) will be calculated as follows: (maximum diameter on expiration (IVC max) - minimum diameter on inspiration (IVC min).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 1735281Bakker J, Vincent JL, Gris P, Leon M, Coffernils M, Kahn RJ. Veno-arterial carbon dioxide gradient in human septic shock. Chest. 1992 Feb;101(2):509-15. doi: 10.1378/chest.101.2.509.
- Background: PubMed 32377433Bitar ZI, Maadarani OS, El-Shably AM, Elshabasy RD, Zaalouk TM. The Forgotten Hemodynamic (PCO2 Gap) in Severe Sepsis. Crit Care Res Pract. 2020 Jan 7;2020:9281623. doi: 10.1155/2020/9281623. eCollection 2020.
- Background: PubMed 26283755Blanco P, Aguiar FM, Blaivas M. Rapid Ultrasound in Shock (RUSH) Velocity-Time Integral: A Proposal to Expand the RUSH Protocol. J Ultrasound Med. 2015 Sep;34(9):1691-700. doi: 10.7863/ultra.15.14.08059. Epub 2015 Aug 17.
- Background: PubMed 1303622Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
- Individual participant dataSharing planned: Undecided
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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.
alhadad a ali, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 GAP in people with Septic Shock, run by Sohag 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 2 inclusion and 4 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 7 Nov 2023. 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?
Contact islam i Ahmed, assisstant lecturer (01090579066, islam.mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
co2 Gap changes (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119815, which also lists 4 linked publications.
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 7 Nov 2023.