Can transthoracic echocardiography predict fluid responsiveness in shock after a mini-fluid challenge?
| ISRCTN | ISRCTN10524328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10524328 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/11/2013
- Registration date
- 12/12/2013
- Last edited
- 11/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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
Contact information
Scientific
Department of Critical Care Medicine
Affiliated Provincial Hospital of Anhui Medical University
No. 17, Lujiang Road
Hefei
230001
China
Study information
| Study design | Prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Can transthoracic echocardiography predict fluid responsiveness in shock after 50 ml crystal solution over 10 seconds? A mini-fluid challenge study |
| 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(s) | The Medical Ethics Committee of Anhui Provincial Hospital, 29/03/2013 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2013 |
| Overall study end date | 31/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 55 |
| 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 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
Study participating centre
230001
China
Sponsor information
Hospital/treatment centre
Department of Critical Care Medicine
No. 17, Lujiang Road
Hefei
230001
China
"ROR" |
https://ror.org/03n5gdd09 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/05/2014 | Yes | No |
Editorial Notes
11/07/2017: Plain English summary added.
