NCT04455477

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

May 16, 2020

Last Update Submit

June 28, 2020

Conditions

Keywords

Congestive Heart FailureNesiritide

Outcome Measures

Primary Outcomes (2)

  • Changes of cardiac output

    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

    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 Outcomes (2)

  • Changes of cardiac function curve

    Before and 30-min after using a standard dose of Nesiritide

  • Changes of venous return curve

    Before and 30-min after using a standard dose of Nesiritide

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Congestive heart failure patients relying on mechanical ventilation and therefore decide to try the Nesiritide.

You may qualify if:

  • Age≥18 years;
  • Congestive Heart Failure;
  • With mechanical ventilation;
  • With hemodynamic monitoring devices;
  • The physicians made the decision of using Nesiritide.

You may not qualify if:

  • Unstable hemodynamic status;
  • Severe renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Xuhui, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2020

First Posted

July 2, 2020

Study Start

May 14, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Our institution did not approve this.

Locations