Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients

NCT03179215 | Completed DMC

• 1 other identifier: N-35 -2017
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• dynamic arterial elastance

  confirm the ability of non invasive (Eadyn) for predicting arterial pressure response to fluid challenge in septic patients

  6 month

Interventions

fluid challange DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Trauma & Surgical ICU. New Emergency Hospital (185 Hospital)

Cairo, 9999, Egypt

Location

Related Publications (2)

• 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.

  PMID: 25407570 BACKGROUND

• 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.

  PMID: 25230102 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ahmed m mukhtar, proffesor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia, ICU and pain management assistant lecturer ,Aswan University

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

EG (1)