- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455477
Nesiritide for Ventilated Congestive Heart Failure (HENCHF)
June 28, 2020 updated by: Shanghai Zhongshan Hospital
Hemodynamic Effects of Nesiritide on Congestive Heart Failure Patients Receiving Mechanical Ventilation: A Prospective Observational Study
The congestive heart failure is a common disease among patients who receive cardiac surgery and may lead to prolonged ventilation support.
Nesiritide was a potential therapy for congestive heart failure.
This study aimed to compare the Nesiritide induced hemodynamical status changes among congestive heart failure patients with invasive ventilation support.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Xuhui, Shanghai, China, 200032
- Recruiting
- Zhongshan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.
Description
Inclusion Criteria:
- Age≥18 years;
- Congestive Heart Failure;
- With mechanical ventilation;
- With hemodynamic monitoring devices;
- The physicians made the decision of using Nesiritide.
Exclusion Criteria:
- Unstable hemodynamic status;
- Severe renal dysfunction.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of cardiac output
Time Frame: Before and 30-min after using a standard dose of Nesiritide
|
Changes of cardiac output measured by hemodynamical monitoring tools
|
Before and 30-min after using a standard dose of Nesiritide
|
Changes of systemic filling pressure
Time Frame: Before and 30-min after using a standard dose of Nesiritide
|
Changes of the intercept of regression line of paired VR-RAP points at different PEEP levels.
|
Before and 30-min after using a standard dose of Nesiritide
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of cardiac function curve
Time Frame: Before and 30-min after using a standard dose of Nesiritide
|
Using body position changes (±15°) to simulate the change of preload, and therefore depicte the Starling curve
|
Before and 30-min after using a standard dose of Nesiritide
|
Changes of venous return curve
Time Frame: Before and 30-min after using a standard dose of Nesiritide
|
Changes of venous return curve depicted by different PEEP setting
|
Before and 30-min after using a standard dose of Nesiritide
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 14, 2020
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
May 16, 2020
First Submitted That Met QC Criteria
June 28, 2020
First Posted (ACTUAL)
July 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 2, 2020
Last Update Submitted That Met QC Criteria
June 28, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2020-056R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Our institution did not approve this.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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