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Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

Primary Purpose

Fluid Responsiveness, Echocardiography

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluid Responsiveness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • faculty of medicine, Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

echocardiography guided fluid resuscitation

clinically guided fluid resuscitation

Arm Description

Outcomes

Primary Outcome Measures

The impact of echocardiography guided fluid resuscitation
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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2017
Last Updated
December 30, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03296319
Brief Title
Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.
Official Title
Echocardiography Guided Fluid Resuscitation in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Responsiveness, Echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
echocardiography guided fluid resuscitation
Arm Type
Active Comparator
Arm Title
clinically guided fluid resuscitation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Echocardiography
Intervention Description
Echocardiography guided fluid administration
Primary Outcome Measure Information:
Title
The impact of echocardiography guided fluid resuscitation
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
faculty of medicine, Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
12386506
Citation
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Results Reference
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PubMed Identifier
16714767
Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. doi: 10.1056/NEJMoa062200. Epub 2006 May 21.
Results Reference
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PubMed Identifier
20975548
Citation
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Results Reference
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PubMed Identifier
19593546
Citation
Squara P, Cecconi M, Rhodes A, Singer M, Chiche JD. Tracking changes in cardiac output: methodological considerations for the validation of monitoring devices. Intensive Care Med. 2009 Oct;35(10):1801-8. doi: 10.1007/s00134-009-1570-9. Epub 2009 Jul 11.
Results Reference
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PubMed Identifier
21508838
Citation
Cecconi M, Parsons AK, Rhodes A. What is a fluid challenge? Curr Opin Crit Care. 2011 Jun;17(3):290-5. doi: 10.1097/MCC.0b013e32834699cd.
Results Reference
result
PubMed Identifier
21729812
Citation
Hofer CK, Cannesson M. Monitoring fluid responsiveness. Acta Anaesthesiol Taiwan. 2011 Jun;49(2):59-65. doi: 10.1016/j.aat.2011.05.001. Epub 2011 Jun 24.
Results Reference
result
PubMed Identifier
21792055
Citation
Vincent JL. "Let's give some fluid and see what happens" versus the "mini-fluid challenge". Anesthesiology. 2011 Sep;115(3):455-6. doi: 10.1097/ALN.0b013e318229a521. No abstract available.
Results Reference
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PubMed Identifier
27536694
Citation
Frazee E, Kashani K. Fluid Management for Critically Ill Patients: A Review of the Current State of Fluid Therapy in the Intensive Care Unit. Kidney Dis (Basel). 2016 Jun;2(2):64-71. doi: 10.1159/000446265. Epub 2016 May 18.
Results Reference
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PubMed Identifier
12065368
Citation
Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
Results Reference
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PubMed Identifier
3928249
Citation
Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
Results Reference
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PubMed Identifier
25185073
Citation
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PubMed Identifier
18467896
Citation
Teboul JL, Monnet X. Prediction of volume responsiveness in critically ill patients with spontaneous breathing activity. Curr Opin Crit Care. 2008 Jun;14(3):334-9. doi: 10.1097/MCC.0b013e3282fd6e1e.
Results Reference
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Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

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