Echocardiography Guided Fluid Resuscitation in Critically Ill Patients.

NCT03296319 | Completed

• 1 other identifier: Echocardiography guided fluid
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fluid Responsiveness; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

echocardiography guided fluid resuscitation

ACTIVE COMPARATOR

Device: Echocardiography

clinically guided fluid resuscitation

EXPERIMENTAL

Device: Echocardiography

Interventions

Echocardiography DEVICE

Echocardiography guided fluid administration

clinically guided fluid resuscitation; echocardiography guided fluid resuscitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Bad echocardiographic window
• APACHE II score \< 25.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

faculty of medicine, Assiut university

Asyut, 71515, Egypt

Location

Related Publications (12)

• 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. doi: 10.1097/00075198-200206000-00010.

  PMID: 12386506 RESULT

• 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.

  PMID: 16714767 RESULT

• 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.0b013e3181feeb15.

  PMID: 20975548 RESULT

• 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.

  PMID: 19593546 RESULT

• 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.

  PMID: 21508838 RESULT

• 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.

  PMID: 21729812 RESULT

• 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.

  PMID: 21792055 RESULT

• 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.

  PMID: 27536694 RESULT

• 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.

  PMID: 12065368 RESULT

• 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.

  PMID: 3928249 RESULT

• 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.

  PMID: 25185073 RESULT

• 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.

  PMID: 18467896 RESULT

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: September 28, 2017
• Study Start: January 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

EG (1)