ShockNCT05679778
PCO2 Gab Marker of Tissue Adequacy of Cardiac Output in Shock State
An observational study of Shock, run by Assiut University.
Trial summary
1. To assess validity of of central and pulmonary veno - arterial CO2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation. 2. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shock
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 30 Jan 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All critical ill-patients of all age groups, who presented shocked, with good echocardiographic window, with CVC insertion.
Who may be able to join
- all critical ill-patients with acute physiological assessment and chronic health evaluation II score (APACHE II score)≥25 with central line insertion, in the critical care uint of internal medicine department of Assuit university hospital in the period between January 2023 to January 2024.
Who cannot join
- Pateints with poor echocardiographic window.
- Pateints with APACHE II score < 25.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PCO2 Gab as a Marker of Tissue Adequacy of Cardiac Output in Sever Shock State, Compared to Other Tissue Perfusion Indicators.
- To assess validity of of central and pulmonary veno - arterial CO2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation.
- comparison between PCO2 gab and left ventricular outflow tract velocity time integral to determine whether to continue or stop resuscitation and whether PCO2 gab is a surrogate of cardiac output or not.
Read the detailed description
Assessing the adequacy of oxygen delivery with oxygen requirements is one of the key-goal of hemodynamic resuscitation. Clinical examination, lactate and central or mixed venous oxygen saturation (SvO2 an ScvO2 respectively) all have their limitations (Gavelli et al., 2019). The veno- arterial difference in CO2 tension (delta CO2 or PCO2 gap) is not indicator of anaerobic metabolism since it is influenced by the oxygen consumption. By contrast, it reliably indicates whether blood flow to remove is sufficient to carry CO2 from prepheral tissues to the lung in view of its clearance: it, thus, reflects the adequacy of cardiac output with the metabolic condition (valley et al., 2013). The gap is a marker of adequacy of venous blood flow to remove CO2 produced rather than a marker of tissue hypoxia (Vallet et al., 2013).
The gab can be calculated from simultaneous sampling of central venous blood from a central vein catheter and arterial blood.
Determining the delta PCO2 during resuscitation of septic shock Patients might be useful when deciding when to continue resuscitation despite a central venous oxygen saturation>70% associated with elevated blood lactate levels. because a high blood lactate level is not a discriminatory factor in determining the source of that stress, an increased delta PCO2 (>6 mmHg) could be used to identify Patients who still remain inadequately resuscitated.
Fluid responsiveness in shocked patients is conventionally defined as an increase of at least 10% to 15% in stroke volume in response to a fluid challenge. Assessment of response to a fluid challenge can be guided with echocardiography. It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VI) immediately before and after fluid challenge (miller et al; 2016).
- Conditions
- Shock
- Keywords
- Delta PCO2 gap, Echocardiography, Left ventricle outflow tract velocity
- Medical subject headings
- Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of heamodynamic state, need of fluid resuscitation and inotropes.
Assessing need of fluid resuscitation and need of inotropes to continue resuscitation to maintain stable heamodynamic status.
Measured: January 2023 to January 2024
Secondary outcomes (1)
Duration of hospital stay, time to control various clinical and laboratory abnormalities (BP, PP, RR, lactate, renal chemistry) and development of complications as; pulmonary edema and use of mechanical ventilation.
Use of delta PCO2 in assessing of hemodynamic stability to shortcut hospital stay, time to control clinical and laboratory abnormalities and decrease the possibility of development of complications as pulmonary edema and use of mechanical ventilation.
Measured: January 2023 to January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Muhammad Abd Elghany, Assiut University
- Investigators
- Khaled Ali, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679778
- Sponsor's protocol ID
- PCO2 gab in shock state
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gavelli F, Teboul JL, Monnet X. How can CO2-derived indices guide resuscitation in critically ill patients? J Thorac Dis. 2019 Jul;11(Suppl 11):S1528-S1537. doi: 10.21037/jtd.2019.07.10.
PubMed 31388457
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCO2 Gab as a Marker of Tissue Adequacy of Cardiac Output in Sever Shock State, Compared to Other Tissue Perfusion Indicators.
- ClinicalTrials.gov ID
- NCT05679778
- Acronym / sponsor ID
- PCO2 gab in shock state
- Conditions
- Shock
- Keywords
- Delta PCO2 gap, Echocardiography, Left ventricle outflow tract velocity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 11 Jan 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.
- To assess validity of of central and pulmonary veno - arterial CO2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation.
- comparison between PCO2 gab and left ventricular outflow tract velocity time integral to determine whether to continue or stop resuscitation and whether PCO2 gab is a surrogate of cardiac output or not.
Detailed description
Assessing the adequacy of oxygen delivery with oxygen requirements is one of the key-goal of hemodynamic resuscitation. Clinical examination, lactate and central or mixed venous oxygen saturation (SvO2 an ScvO2 respectively) all have their limitations (Gavelli et al., 2019). The veno- arterial difference in CO2 tension (delta CO2 or PCO2 gap) is not indicator of anaerobic metabolism since it is influenced by the oxygen consumption. By contrast, it reliably indicates whether blood flow to remove is sufficient to carry CO2 from prepheral tissues to the lung in view of its clearance: it, thus, reflects the adequacy of cardiac output with the metabolic condition (valley et al., 2013). The gap is a marker of adequacy of venous blood flow to remove CO2 produced rather than a marker of tissue hypoxia (Vallet et al., 2013).
The gab can be calculated from simultaneous sampling of central venous blood from a central vein catheter and arterial blood.
Determining the delta PCO2 during resuscitation of septic shock Patients might be useful when deciding when to continue resuscitation despite a central venous oxygen saturation>70% associated with elevated blood lactate levels. because a high blood lactate level is not a discriminatory factor in determining the source of that stress, an increased delta PCO2 (>6 mmHg) could be used to identify Patients who still remain inadequately resuscitated.
Fluid responsiveness in shocked patients is conventionally defined as an increase of at least 10% to 15% in stroke volume in response to a fluid challenge. Assessment of response to a fluid challenge can be guided with echocardiography. It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VI) immediately before and after fluid challenge (miller et al; 2016).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All critical ill-patients of all age groups, who presented shocked, with good echocardiographic window, with CVC insertion.
Key inclusion criteria (1 listed)
- all critical ill-patients with acute physiological assessment and chronic health evaluation II score (APACHE II score)≥25 with central line insertion, in the critical care uint of internal medicine department of Assuit university hospital in the period between January 2023 to January 2024.
Key exclusion criteria (2 listed)
- Pateints with poor echocardiographic window.
- Pateints with APACHE II score < 25.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Improvement of heamodynamic state, need of fluid resuscitation and inotropes.
Time frame: January 2023 to January 2024
Assessing need of fluid resuscitation and need of inotropes to continue resuscitation to maintain stable heamodynamic status.
1 secondary outcome
Duration of hospital stay, time to control various clinical and laboratory abnormalities (BP, PP, RR, lactate, renal chemistry) and development of complications as; pulmonary edema and use of mechanical ventilation.
Time frame: January 2023 to January 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 31388457Gavelli F, Teboul JL, Monnet X. How can CO2-derived indices guide resuscitation in critically ill patients? J Thorac Dis. 2019 Jul;11(Suppl 11):S1528-S1537. doi: 10.21037/jtd.2019.07.10.
- Individual participant dataSharing planned: Undecided
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Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
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The Danish Out-of-Hospital Cardiac Arrest Study
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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.
Khaled Ali principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Assiut University.
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 1 inclusion and 2 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Manal Abdelghany (01125767752, manalmlmohamed145@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of heamodynamic state, need of fluid resuscitation and inotropes. (time frame: January 2023 to January 2024). 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 NCT05679778, which also lists 1 linked publication.
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 11 Jan 2023.