Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

Echocardiography Clinical Trial

Official title:

Echocardiography Guided Fluid Resuscitation in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03296319
• Other study ID #: Echocardiography guided fluid
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Echocardiography
• Fluid Responsiveness

Intervention

Device:
• Echocardiography
Echocardiography guided fluid administration

Locations

Country	Name	City	State
Egypt	faculty of medicine, Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3 — View 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. Review. — View Citation

Chen C, Kollef MH. Conservative fluid therapy in septic shock: an example of targeted therapeutic minimization. Crit Care. 2014 Aug 29;18(4):481. doi: 10.1186/s13054-014-0481-5. Review. — View 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. Review. — View 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. Review. — View Citation

Jonas MM, Tanser SJ. Lithium dilution measurement of cardiac output and arterial pulse waveform analysis: an indicator dilution calibrated beat-by-beat system for continuous estimation of cardiac output. Curr Opin Crit Care. 2002 Jun;8(3):257-61. Review. — View 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. — View Citation

Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review. — View 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-managemen — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline

External Links

•   Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock