Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic

Cardiac Output, Low Clinical Trial

Official title:

Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06326762
• Other study ID #: younes
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: March 2024
• Source: Mohammed VI University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiac Defect
• Cardiac Output, Low
• Cardiomyopathies

Intervention

Other:
• comparaison
description indicate

Locations

Country	Name	City	State
Morocco	younes Oujidi	Berkane

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed VI University Hospital

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gapCO2	significative in cardiomyopathy septic	10 mounths