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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04455477
Other study ID # B2020-056R
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 14, 2020
Est. completion date December 31, 2021

Study information

Verified date June 2020
Source Shanghai Zhongshan Hospital
Contact Zhe Luo, MD
Phone +8613916127028
Email luo.zhe@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Nesiritide
The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.

Locations

Country Name City State
China Zhongshan Hospital Xuhui Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of cardiac output Changes of cardiac output measured by hemodynamical monitoring tools Before and 30-min after using a standard dose of Nesiritide
Primary Changes of systemic filling pressure 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 Changes of cardiac function curve 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
Secondary Changes of venous return curve Changes of venous return curve depicted by different PEEP setting Before and 30-min after using a standard dose of Nesiritide
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