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Completed

NCT Number: NCT03296319

Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

To compare between the impact of echocardiography guided fluid resuscitation and clinically guided fluid resuscitation on critically ill patients in hospital outcome.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Assiut university

Asyut, 71515, Egypt

About this study

Resuscitation often requires the infusion of intravenous fluid in an effort to reverse organ dysfunction. The harms of inappropriate use of fluid are becoming increasingly apparent The question of whether the patient improves with fluid, additional vasopressors or inotropes can be difficult to answer. The gold standard for assessing fluid responsiveness to guide fluid administration in critically ill patients is to perform a fluid challenge. The rationale for volume expansion is to increase the cardiac output (CO) and oxygen delivery to ultimately improve tissue oxygenation. This involves the infusion of a specific amount of intravenous fluid to assess ventricular preload reserve and subsequent systemic haemodynamic effects. In a patient with acute hemodynamic instability, a fluid challenge will cause an increase in stroke volume, according to the Frank-Starling curve. This increase in stroke volume has a salutary effect because it improves tissue perfusion. In contrast, higher hydrostatic pressures in the vascular system predispose the patient to edema, organic dysfunction, and increased risk of in-hospital mortality.

Fluid responsiveness is conventionally defined as an increase of at least 10% to 15% in SV in response to a fluid challenge, which is a reflection of the limits of precision of the technology used.

Assessment of the response in flow to a fluid challenge can be guided with echocardiography. It is achieved by measuring left ventricular outflow tract velocity time integral (LVOT VTI) immediately before and after fluid challenge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1- All Critical ill-patients with Acute Physiologic Assessment and Chronic Health Evaluation II score (APACHE II score)≥ 25

Exclusion criteria

  • Bad echocardiographic window
  • APACHE II score < 25.

Treatment and study plan

Echocardiography

Device

Echocardiography guided fluid administration

Primary outcomes

  1. The impact of echocardiography guided fluid resuscitation

    Time frame: Baseline

    we will compare the results of fluid administration between two groups of patients with APACHE II score > 25: the first group using clinical sense only and the other group using transthoracic echocardiography including: The sample box of PW Doppler will be placed at thelevel of the aortic valve or within 1 cm of it, in the LVOT. Peak velocity variation of 12% before and after 250 cc normal saline challenge in adults predicts fluid responsiveness (12) and VTI variation is also predictive. The percentage variations in SV, VTI or peak velocity are calculated using the following equation: variations =100 x svmax-svmin/(svmax+svmin) x 0.5.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Echocardiography Guided Fluid Resuscitation in Critically Ill Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2017
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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