NCT06326762

Brief 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

March 3, 2024

Last Update Submit

March 17, 2024

Conditions

Keywords

cardiacCO2septic

Outcome Measures

Primary Outcomes (1)

  • gapCO2

    significative in cardiomyopathy septic

    10 mounths

Study Arms (2)

Myocardial Dysfunction

Other: comparaison

No Myocardial Dysfunction

Other: comparaison

Interventions

description indicate

Myocardial DysfunctionNo Myocardial Dysfunction

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

younes Oujidi

Berkane, 9999, Morocco

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 22, 2024

Study Start

January 1, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations