Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure

Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study

Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.

Study Overview

• Status: Completed
• Conditions: Circulatory Failure
• Intervention / Treatment: Drug: Normal Saline Flush, 0.9% Injectable Solution

Detailed Description

Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Egypt
  • Shebin El-kom
    • Cairo, Shebin El-kom, Egypt, 32511
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

in a general adult critical care unit (CCU) at Menoufia University Hospitals

Description

Inclusion Criteria:

• Patients with acute circulatory failure
• Mechanically ventilated & sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
• Systemic inflammatory response syndrome
• Septic shock
• Controlled massive hemorrhage

Exclusion Criteria:

• Age of less than 18 years
• Cardiomyopathy
• Pulmonary edema
• Morbid obesity
• Pregnancy
• Increased intracranial tension
• Valvular heart disease
• Myocardial ischemia or infarction before the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

The study group; As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.

Drug: Normal Saline Flush, 0.9% Injectable Solution; As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.; Other Names: normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aortic blood flow velocity Time Integral changes from the baseline	[cm]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume change from the baseline	[ml/beat]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
cardiac output change from the baseline	[ liter/minute]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
heart rate change from the baseline	[beats/minute]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
systolic blood pressure change from the baseline	[mmHg]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Diastolic blood pressure change from the baseline	[mmHg]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Central venous pressure change from the baseline	[Cm water]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Mean arterial blood pressure change from the baseline	[mmHg]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end systolic diameter change from the baseline	[Cm]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end diastolic diameter change from the baseline	[Cm]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Aortic root diameter change from the baseline	[Cm]	Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Abd-Elazeem A Elbakry, M.D, Menofia University

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): February 26, 2019

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 4, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 2017/3/1/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the paper protocol only we share if the paper is published in a closed access journal. For open access no problem for sharing the whole data
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: through the clinical trial registry site or contact by my e-mail
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No