Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Norepinephrine Exerts an Inotropic Effect at the Early Phase of Human Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02750683
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hamzaoui Olfa, Hopital Antoine Beclere

Brief Summary:
Norepinephrine (NE) is a potent vasopressor used in septic shock to reverse hypotension. Early infusion of NE was associated with a favorable clinical outcome in a large cohort of patients . When administered early, NE increases cardiac output (CO) in patients with septic shock . This effect was suggested to be mainly related to an increased cardiac preload via the α-adrenergic-mediated decrease in systemic venous capacitance . Whether NE exerts a positive effect on cardiac contractility through β1-adrenergic stimulation is unclear. On the one hand, the sensitivity of β1-adrenergic receptors can be abnormally reduced in septic conditions. On the other hand, such a sepsis-induced down-regulation of β1-adrenergic receptors may occur relatively late and thus, might not be observed when NE is administered early. Our study was designed to examine the inotropic effects of NE when administered in the early phase of human septic shock

Condition or disease
Septic Shock

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Norepinephrine Exerts an Inotropic Effect at the Early Phase of Human Septic
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. The changes in left ventricular ejection fraction [ Time Frame: 2 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an age of more than 18 years old, admitted to intensive care unit with septic shock and a mean arterial pressure of less than 65mmHg.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750683


Sponsors and Collaborators
Hopital Antoine Beclere
Investigators
Layout table for investigator information
Principal Investigator: Olfa Hamzaoui, MD Hopital Antoine Beclere

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hamzaoui Olfa, MD, Hopital Antoine Beclere
ClinicalTrials.gov Identifier: NCT02750683     History of Changes
Other Study ID Numbers: 2011-A-01230-41
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hamzaoui Olfa, Hopital Antoine Beclere:
inotropic effect, norepinephrine, septic shock,

Additional relevant MeSH terms:
Layout table for MeSH terms
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents