Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06326762
Other study ID # younes
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05070819 - Atrial Natriuretic Peptide in Assessing Fluid Status N/A
Recruiting NCT05492968 - The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance Phase 4
Completed NCT03444545 - Continous Cardiac Output - Non-Invasive Evaluation (CONNIE)
Recruiting NCT04064177 - Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Withdrawn NCT03058653 - Use of a Mini-fluid Bolus to Identify Fluid Responsiveness N/A
Completed NCT02880683 - Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study N/A
Recruiting NCT00989508 - Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy Phase 2/Phase 3
Completed NCT04955184 - Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
Completed NCT02964663 - Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery N/A
Completed NCT04641949 - Methoxyflurane and Fentanyl in LBNP Phase 4
Recruiting NCT04191408 - Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery N/A
Completed NCT01892696 - Effects of Inspiratory Flow Waveforms on Preload N/A
Recruiting NCT02728791 - Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution N/A
Completed NCT03930979 - The Effect of Hyperoxia on Cardiac Output
Recruiting NCT04755764 - Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
Enrolling by invitation NCT02702544 - Effect of Passive Leg Raising for Fluid Responsiveness N/A
Completed NCT01880684 - Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac Phase 2
Recruiting NCT05035719 - Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References
Not yet recruiting NCT04774978 - Real-time Continuous Cardiac Output Measurements N/A
Completed NCT02485782 - Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis N/A