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Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

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: NCT03296319
Recruitment Status : Unknown
Verified September 2017 by Mohammed Esam, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 28, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Esam, Assiut University

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

Condition or disease Intervention/treatment Phase
Fluid Responsiveness Echocardiography Device: Echocardiography Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Echocardiography Guided Fluid Resuscitation in Critically Ill Patients
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : March 1, 2019

Arm Intervention/treatment
Active Comparator: echocardiography guided fluid resuscitation Device: Echocardiography
Echocardiography guided fluid administration

Experimental: clinically guided fluid resuscitation Device: Echocardiography
Echocardiography guided fluid administration




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Bad echocardiographic window
  2. APACHE II score < 25.

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): NCT03296319


Contacts
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Contact: Mohammed E Abdelmoniem Sadek, M.B.B.CH +201112554609 m92beh@gmail.com
Contact: Mahmoud A Mahmoud Ashry, Professor +201006901937 mamashry57@yahoo.com

Locations
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Egypt
faculty of medicine, Assiut university
Assiut, Egypt, 71515
Contact: Vice president of graduate studies of Assiut University    +2088 22080150    vp_grad@aun.edu.eg   
Sponsors and Collaborators
Assiut University
Additional Information:
Publications of Results:

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Responsible Party: Mohammed Esam, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03296319    
Other Study ID Numbers: Echocardiography guided fluid
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes