- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679778
PCO2 Gab Marker of Tissue Adequacy of Cardiac Output in Shock State
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Manal Abdelghany
- Phone Number: 01125767752
- Email: manalmlmohamed145@gmail.com
Study Contact Backup
- Name: Khaled Ali
- Phone Number: 01093881684
- Email: khaled.cardio@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pateints with poor echocardiographic window.
- Pateints with APACHE II score < 25.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
January 2023 to January 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
January 2023 to January 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khaled Ali, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCO2 gab in shock state
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shock
-
Assistance Publique - Hôpitaux de ParisTraumabase Group; Capgemini Invent; Ecole polytechnique; EHESS (Ecole des hautes... and other collaboratorsRecruitingWounds and Injuries | Hemorrhagic Shock | Traumatic ShockFrance
-
Biomedizinische Forschungs gmbHMedical University of ViennaCompletedSepsis | Toxic-Shock Syndrome
-
King's College Hospital NHS TrustUniversity Hospital BirminghamCompletedTraumatic Haemorrhagic ShockUnited Kingdom
-
Haukeland University HospitalMinistry of Defence, NorwayCompletedHemorrhagic Shock | Hypovolemic ShockNorway
-
National Institute of Allergy and Infectious Diseases...Completed
-
Massachusetts General HospitalBeth Israel Deaconess Medical Center; Boston Medical Center; Tufts Medical Center and other collaboratorsRecruiting
-
Jason SperryNational Heart, Lung, and Blood Institute (NHLBI)TerminatedHemorrhagic ShockUnited States
-
University of Texas Southwestern Medical CenterUniversity of Washington; Resuscitation Outcomes ConsortiumCompletedHemorrhagic ShockUnited States
-
Ramathibodi HospitalUnknownSeptic Shock | Refractory ShockThailand
-
Assiut UniversityUnknown