Safety and efficacy of cardiac output invasive monitoring in elderly patients
ISRCTN | ISRCTN73335561 |
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DOI | https://doi.org/10.1186/ISRCTN73335561 |
- Submission date
- 30/06/2021
- Registration date
- 09/07/2021
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The optimal treatment for elderly patients with severe heart failure depends on accurate assessment and monitoring.
Pulse-induced contour cardiac output (PiCCO)-based hemodynamic monitoring is a relatively new technology.
This study aims to test the effect of using PiCCO monitoring or noninvasive hemodynamic monitoring on the length of hospital stay.
Who can participate?
Elderly patients with severe heart failure.
What does the study involve?
Between January 2016 and July 2020, patients were enrolled and assigned randomly to the PiCCO group or noninvasive hemodynamic monitoring group using a prospective observational study design. Hospital stay results were evaluated.
What are the possible benefits and risks of participating?
The PiCCo device might be more sensitive than non-invasive monitoring.
PiCCO has the risk of an invasive operation: bleeding, infection, and unsuccessful puncture.
Where is the study run from?
Chinese PLA general hospital (China)
When is the study starting and how long is it expected to run for?
January 2016 to July 2020
Who is funding the study?
Chinese PLA general hospital (China)
Who is the main contact?
Dr Hongwei Liu, qilipingping@163.com
Contact information
Scientific
Chinese PLA General Hospital
28# Fuxing road
Haidian district
Beijng
100853
China
0000-0002-4361-4155 | |
Phone | +86-010-66876349 |
qilipingping@163.com |
Study information
Study design | Single center observational retrospective and prospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
Scientific title | Safety and efficacy of pulse-induced contour cardiac output monitoring in elderly patients with coronary artery disease and severe heart failure at coronary care units |
Study objectives | Early invasive PiCCO monitoring is safe in critically ill elderly patients with severe heart failure. |
Ethics approval(s) | Approved 30/12/2016, The Ethics Review Board of Chinese PLA General Hospital (#28 Fuxing Road, Haidian District, Beijing 100853, China; +86-010-66887329; no email provided), ref: 16BJZ22 |
Health condition(s) or problem(s) studied | Elderly patients with severe heart failure |
Intervention | Between January 2016 and July 2020, 190 elderly patients with severe heart failure were enrolled and assigned randomly (using a random number generator) to the PiCCO group (89 patients) or noninvasive hemodynamic monitoring group (101 patients). Hospital stay results were evaluated. The participants were followed up for at least 1 year. |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | PiCCO cardiac output monitor |
Primary outcome measure | Length of hospital stay measured using patient records at the end of the study |
Secondary outcome measures | There are no secondary outcome measures |
Overall study start date | 01/01/2016 |
Completion date | 31/07/2020 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 191 |
Total final enrolment | 191 |
Key inclusion criteria | 1. Known history of coronary heart disease 2. Orthopnea (inability to lie down) 3. Wet rales in the lungs 4. Edema in the lower extremities 5. Echocardiography showing left ventricular end-diastolic diameter of >50 mm and left ventricular ejection fraction(LVEF) of <50%, or chest X-ray showing pulmonary congestion or edema 6. Type I respiratory failure (partial pressure of oxygen of <50 mm Hg even after oxygen therapy, requiring tracheal intubation and mechanical ventilation after conventional treatments, such as cardiotonic therapy, diuretics, and vasoactive drugs). 7. Aged 65 - 100 years |
Key exclusion criteria | 1. Heart failure 2. Uncontrolled severe infection, and pulmonary diseases |
Date of first enrolment | 01/01/2016 |
Date of final enrolment | 31/07/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Haidian district
Beijing
100853
China
Sponsor information
Hospital/treatment centre
28# Fuxing road
Haidian district
Beijing
100853
China
Phone | +86-13811490651 |
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liuhw928@sina.com | |
Website | http://www.301hospital.com.cn/en2012/web/Introduction.html |
https://ror.org/04gw3ra78 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
Intention to publish date | 09/12/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | 19/10/2022 | 25/10/2022 | Yes | No |
Editorial Notes
25/10/2022: Publication reference added.
09/09/2022: The intention to publish date has been changed from 30/07/2021 to 09/12/2022.
09/07/2021: Internal review.
07/07/2021: Trial's existence confirmed by Health Bureau of logistics support department Chinese PLA General Hospital.