Gap co2NCT06326762
Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic
An observational study of Gap co2 and Cardiac Output, Low, run by Mohammed VI University Hospital at 1 site in Morocco.
Trial summary
the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gap co2, Cardiac Output, Low, Cardiac Defect
- What is being tested?
- comparaison
- How many people
- 98 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Jan 2023to 30 Oct 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We included patients diagnosed with sepsis/septic shock admitted at various points in time to the intensive care units of the Mohammed VI University Hospital in Oujda.
Who may be able to join
- Patients admitted to the intensive care unit
- sepsis or septic shock
- at least one echocardiogram and were monitored by pulse wave contour analysis
- stay of 72 hours in the intensive care unit
Who cannot join
- Patients without sepsis or septic shock.
- Patients with COVID-19.
- Patients who died within 48 hours of hospitalization.
- Cases with incomplete medical records or patients not monitored.
- Patient with pre-existing cardiac conditions.
- post-operative patients from cardiac and thoracic surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.
Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index < 2.2 L/min/m². The mortality rate was significantly increased at 73.7%.
- Conditions
- Gap co2, Cardiac Output, Low, Cardiac Defect
- Being tested
- comparaison
- Keywords
- cardiac, CO2, septic
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparaisonOther
description indicate
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Dysfunction | Not described Receives: Other: comparaison | |
| No Myocardial Dysfunction | Not described Receives: Other: comparaison |
What is being measured
The primary outcome is the main question the study is designed to answer.
gapCO2
significative in cardiomyopathy septic
Measured: 10 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gap co2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Oujidi, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326762
- Sponsor's protocol ID
- younes
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic
- ClinicalTrials.gov ID
- NCT06326762
- Acronym / sponsor ID
- younes
- Conditions
- Gap co2, Cardiac Output, Low, Cardiac Defect
- Keywords
- cardiac, CO2, septic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 22 Mar 2024 (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 investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.
Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index < 2.2 L/min/m². The mortality rate was significantly increased at 73.7%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myocardial Dysfunction | – | Other: comparaison |
| No Myocardial Dysfunction | – | Other: comparaison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We included patients diagnosed with sepsis/septic shock admitted at various points in time to the intensive care units of the Mohammed VI University Hospital in Oujda.
Key inclusion criteria (4 listed)
- Patients admitted to the intensive care unit
- sepsis or septic shock
- at least one echocardiogram and were monitored by pulse wave contour analysis
- stay of 72 hours in the intensive care unit
Key exclusion criteria (6 listed)
- Patients without sepsis or septic shock.
- Patients with COVID-19.
- Patients who died within 48 hours of hospitalization.
- Cases with incomplete medical records or patients not monitored.
- Patient with pre-existing cardiac conditions.
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 |
|---|---|---|
| comparaisondescription indicate | Other | Myocardial Dysfunction, No Myocardial Dysfunction |
Primary outcome
gapCO2
Time frame: 10 mounths
significative in cardiomyopathy septic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Gap co2
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruitingObservational study
Central Venous vs Arterial Blood Gas and CO2 Gap in Critically Ill Patients With and Without Diabetes
Critical Illness, Diabetes Mellitus
Not yet recruitingObservational study
Peripheral Perfusion and Outcomes in ICU Patients With Sepsis
SEPSIS, Septic Patients
Not yet recruitingObservational study
Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass
Patient Undergoing CABG Surgery, Ischemic Heart Disease Patients
Active, not recruitingObservational study
Critical Closing Pressure and PCO₂ Gap in Fluid Resuscitation for Septic Shock
Septic Shock, Fluid Resuscitation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gap co2 and Cardiac Output, Low, run by Mohammed VI University Hospital at 1 site in Morocco.
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 4 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: finished, as of the sponsor's last update on 22 Mar 2024. 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 Morocco. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
gapCO2 (time frame: 10 mounths). 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 22 Mar 2024.