- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02750683
Norepinephrine Exerts an Inotropic Effect at the Early Phase of Human Septic Shock
Norepinephrine Exerts an Inotropic Effect at the Early Phase of Human Septic
Study Overview
Status
Conditions
Detailed Description
It is a prospective observational study, in two 15-bed intensive care units, including adult patients with septic shock who have a mean arterial pressure (MAP) < 65 mmHg within the first three hours after the start of resuscitation. For every patient, the physician taking care of the patient should have already decided to initiate NE or to increase its dose in order to achieve a MAP value of at least 65mmHg without any other change of the associated therapy (fluid administration, ventilator settings, other drugs). The study was approved by the institutional review board of our institution (Comité de Protection des Personnes, Paris-Ile-de-France VII). Informed patient (or next-of-kin) consent was obtained from all patients.
Data collection: demographic and clinical information (origin of sepsis, major elements of the clinical history) were collected. The volume of fluids administered before inclusion, the use of mechanical ventilation and the interval time between the start of resuscitation and inclusion (T0) were also recorded.
Hemodynamic data: At T0 and at T1, defined as the time a MAP value of at least 65 mmHg was reached after initiating NE (or increasing its dose), heart rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), MAP and blood lactate concentration were collected.
Transthoracic echocardiographic data: Echocardiographic measurements were performed at T0 and T1.
Transthoracic echocardiographic (TTE) examination were performed with 3.75 MHZ probe using a CX50 Philips and a Vivid i (GE Healthcare) machine. Patients were on supine flat or lateral supine positions depending on their respiratory tolerance. A four- and five-chamber apical views were used in order to collect the following variables: left ventricular ejection fraction (LVEF) calculated by the biplane method of disks summation (modified Simpson's rule), velocity-time integral (VTI) of the sub-aortic flow, tissue Doppler imaging of tricuspid annular motion (Sa), tricuspid annular plane systolic excursion (TAPSE) measured by M-mode echocardiography, the peak early (E) and late (A) transmitral flow velocity, the mean early diastolic velocity (Ea) of the lateral mitral annulus, the ratios E/A and E/Ea and tissue Doppler imaging of mean systolic velocity of the lateral mitral annulus (Sm). All the parameters were averaged over three beats or five beats in case of atrial fibrillation.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age more than 18 years old
- Septic shock
- Mean arterial pressure<65mmHg
Exclusion Criteria:
- Age less than 18 yeras old
- Pregnancy
- moribond patients
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The changes in left ventricular ejection fraction
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olfa Hamzaoui, MD, Hôpital Antoine Béclère
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 2011-A-01230-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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