Clinical trial NCT03179215: Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients
Official title: Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with the diagnosis of sepsis who will be admitted to the Trauma and Surgical Intensive Care Unit (SICU) of Kasralainy School of Medicine,Cairo University during a 6-month period (from March 2017 to September 2017) will be enrolled in the study.Sepsis is defined according to Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016 as life-threatening organ dysfunction due to a dysregulated host response to infection.10 Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities substantially increase mortality.

Brief summary: Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining MAP above a minimum level has been recommended in order to prevent further tissue hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response to volume expansion (VE) in hypotensive, preload-dependent septic patients.

Detailed description: After approval from the ethics and research committee of Faculty of Medicine, Cairo University, an informed consent will be obtained from each patient's next of kin. Arteial cathter will be inserted in radial artery and connected through an arterial line to invasive arterial blood pressure monitor. Electrical Cardiometry will be attached to patient through the placement of four skin sensors on the neck and left side of the thorax12. A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge (FC).

Eligibility criteria: Inclusion Criteria:

* Adult patients (more than 18 years).
* Sepsis as a cause of admission.

Exclusion Criteria:

* • Patients younger than 18 years of age.

  * Pregnant females.
  * Trauma as a cause of intensive care unit (ICU)admission.
  * Known medical history of vasodilator therapy.
  * Cardiac arrhythmias.
  * Any absolute contraindication for fluid administration such as congestive heart failure, pulmonary edema and/or fluid overload

Primary outcomes:
measure: dynamic arterial elastance
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Trauma & Surgical ICU. New Emergency Hospital (185 Hospital)
Study officials:
affiliation: Cairo University
name: ahmed m mukhtar, proffesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6.
citation: Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.