Condition category
Signs and Symptoms
Date applied
26/11/2013
Date assigned
12/12/2013
Last edited
11/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fluid responsiveness is defined as the ability of the heart to pump more blood in response to fluid administration. Accurate real-time assessment of fluid responsiveness is an important clinical goal. The aim of this study is to find out whether echocardiography (a heart ultrasound scan) can be used predict fluid responsiveness in patients with shock following a low-volume infusion.

Who can participate?
Mechanically ventilated adults with shock (low blood flow to tissues)

What does the study involve?
In all participants echocardiography is performed during a 50 ml fluid infusion over 10 seconds and a further 450 ml over 15 min. The amount of blood pumped by the heart (cardiac output) is recorded. Patients are classified as responders if cardiac output increases by at least 15% following the fluid administration.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Affiliated Provincial Hospital of Anhui Medical University (China)

When is the study starting and how long is it expected to run for?
March to October 2013

Who is funding the study?
Investigator initiated and funded (China)

Who is the main contact?
Mrs Yunfan Wu

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Yunfan Wu

ORCID ID

Contact details

Department of Critical Care Medicine
Affiliated Provincial Hospital of Anhui Medical University
No. 17
Lujiang Road
Hefei
230001
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Can transthoracic echocardiography predict fluid responsiveness in shock after 50 ml crystal solution over 10 seconds? A mini-fluid challenge study

Acronym

Study hypothesis

The trialists hypothesize that a small fluid preload and faster infusion rate can also predict responsiveness. This study aimed to determine whether echocardiographic parameters following a 50 ml infusion of crystalloid solution over 10 s can predict fluid responsiveness in critically ill patients with hypovolemic or septic shock.

Ethics approval

The Medical Ethics Committee of Anhui Provincial Hospital, 29/03/2013

Study design

Prospective trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Hypovolemic or septic shock

Intervention

The study will involve 55 mechanically ventilated adults with hypovolemic or septic shock. The attending physician clinically determined the need for volume expansion (VE). If patients were treated with norepinephrine, the dose remained unchanged from before VE until all hemodynamic measurements were complete.

Echocardiography was performed during a 50 ml infusion of crystalloid solution over 10 s and a further 450 ml over 15 min. Cardiac output (CO), stroke volume (SV), aortic velocity time index (VTI), and left ventricular ejection fraction (LVEF) were recorded. Echocardiographic parameters were measured using a bedside Phillips IU22 xMATRIX ultrasound system (Royal Philips Electronics; Amsterdam, the Netherlands) with a 3-5 MHz phased-array probe. M-mode (time-motion) echocardiography was employed at the level of the aortic annulus in a two-dimensional view from the parasternal long-axis window. The aortic diameter (D), left ventricular end-diastolic diameter, left ventricular end-systolic diameter and heart rate (HR) were measured. Using the in-built software, the left ventricular end-diastolic volume (LEDV) and left ventricular end-systolic volume (LESV) were determined. In addition, heart rate, blood pressure, CVP and other hemodynamic parameters were recorded throughout the study. Aortic blood flow and velocity time integral (VTI) were obtained from an apical five-chamber view.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Cardiac output (CO)
2. Stroke volume (SV)
3. Aortic velocity time index (VTI)
4. Left ventricular ejection fraction (LVEF)

Secondary outcome measures

Area under the receiver operating characteristic curves (AUC) compared CO variations after 50 ml over 10 s (∆CO50) and 500 ml over 15 min (∆CO500) and the variation of VTI after infusion of 50 ml fluid over 10 s (∆VTI50)

Overall trial start date

01/03/2013

Overall trial end date

31/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Evidence of inadequate tissue perfusion with acute circulatory failure defined as a systolic arterial pressure of 90 mmHg (or a decrease of 40 mmHg in a patient with hypertension)
2. Urine output below 0.5 ml/kg/h for over 1 h
3. Tachycardia (heart rate < 100/min)
4. Mottled skin
5. Clinical diseases of hypovolemic or septic shock associated with a systemic inflammatory response syndrome
6. Septic shock
7. Controlled massive hemorrhage
8. The attending physician clinically determined the need for volume expansion (VE)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

55

Participant exclusion criteria

1. Age < 18 years
2. Moribund
3. Cardiomyopathy
4. Pulmonary edema
5. Increased intracranial pressure
6. Pregnancy
7. Active bleeding
8. Atrial fibrillation
9. Cardiac arrhythmias
10. Myocardial ischemia or infarction within 1 month before the study

Recruitment start date

01/03/2013

Recruitment end date

31/10/2013

Locations

Countries of recruitment

China

Trial participating centre

Affiliated Provincial Hospital of Anhui Medical University
Hefei
230001
China

Sponsor information

Organisation

Affiliated Provincial Hospital of Anhui Medical University (China)

Sponsor details

Department of Critical Care Medicine
No. 17
Lujiang Road
Hefei
230001
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24886990

Publication citations

Additional files

Editorial Notes

11/07/2017: Plain English summary added.