Safety and efficacy of cardiac output invasive monitoring in elderly patients

ISRCTN ISRCTN73335561
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Hongwei Liu
Scientific

Chinese PLA General Hospital
28# Fuxing road
Haidian district
Beijng
100853
China

ORCiD logoORCID ID 0000-0002-4361-4155
Phone +86-010-66876349
Email qilipingping@163.com

Study information

Study designSingle center observational retrospective and prospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleSafety 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 objectivesEarly 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) studiedElderly patients with severe heart failure
InterventionBetween 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)PiCCO cardiac output monitor
Primary outcome measureLength of hospital stay measured using patient records at the end of the study
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/01/2016
Completion date31/07/2020

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants191
Total final enrolment191
Key inclusion criteria1. 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 criteria1. Heart failure
2. Uncontrolled severe infection, and pulmonary diseases
Date of first enrolment01/01/2016
Date of final enrolment31/07/2020

Locations

Countries of recruitment

  • China

Study participating centre

Chinese PLA general hospital
28# Fuxing road
Haidian district
Beijing
100853
China

Sponsor information

Chinese PLA General Hospital
Hospital/treatment centre

28# Fuxing road
Haidian district
Beijing
100853
China

Phone +86-13811490651
Email liuhw928@sina.com
Website http://www.301hospital.com.cn/en2012/web/Introduction.html
ROR logo "ROR" https://ror.org/04gw3ra78

Funders

Funder type

Hospital/treatment centre

Chinese PLA General Hospital

No information available

Results and Publications

Intention to publish date09/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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?
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.