Congenital Heart DiseaseNCT03207295
Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
A study testing Nesiritide and Normal saline in people with Congenital Heart Disease and Total Cavo-pulmonary Connection, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Congenital Heart Disease, Total Cavo-pulmonary Connection
- What is being tested?
- Nesiritide and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective general anesthesia down Fontan surgery patients, postoperative retention of patients with thoracic drainage tube
- Age ≤ 14 years old between hospitalized patients, men and women are not limited
- Postoperative hospital stay> 7 days
- Patients or guardians voluntarily signed informed consent
Who cannot join
- Before the group had serious head trauma need hospitalization or brain surgery patients
- Who received organ transplants
- Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs
- Preoperative cardiogenic shock or hypotension difficult to correct the patient
- Preoperative patients with active arrhythmia
- Preoperative serum creatinine> 1.5mg / dl or need dialysis patients
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- Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)
- Failed Fontan patients requiring secondary surgery
- Patients with allergic to Nesiritide
- The researchers believe that should not participate in the entry of patients
- 3 months before the trial participated in other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality
Yan Jun, MD,PhD, yanjun.1112@aliyun.com
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Center Clinical Study of the Efficacy and Safety of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass. Investigators seek to determine whether nesiritide would improve the early postoperative course after total cavo-pulmonary connection surgery in children.
Read the detailed description
Objective: This study aims to evaluate the efficacy and safety of nesiritide after total cavo-pulmonary connection surgery in children. Investigators hypothesized that compared with placebo, patients assigned to receive nesiritide will improve early postoperative outcomes. Study design: The study is a a single-center, randomized, single-blinded, placebo-controlled, two-arm parallel-group clinical trial, patients undergoing total cavo-pulmonary connection surgery are assigned to receive nesiritide or placebo. A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission. The primary outcome is days of chest drainage. Secondary outcomes included days of hospitalization measures of cardiovascular function, renal function, and adverse events and neurohumoral. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive study drug. All the participants will be followed up during hospitalization .
Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan.
- Being tested
- Nesiritide, Normal saline
- Keywords
- Nesiritide, Total Cavo-Pulmonary Connection, Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission
Normal salineDrug
Normal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children
| Study group | Role | What they receive |
|---|---|---|
| Intervention-Nesiritide | Experimental | A standard dose of Nesiritide(0.001ug/kg/min) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children Receives: Drug: Nesiritide |
| Control-Normal saline | Placebo comparator | Normal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of chest drainage
Investigators will measure the daily chest drainage flow before discharge
Measured: Up to 18 weeks
Secondary outcomes (14)
Days of hospitalization after surgery
Postoperative hospital days
Measured: Up to 20 weeks
Postoperative early survival
Number of days alive within 30 days of surgery.
Measured: The 30th day after surgery
Measures of heart rate
Investigators will measure the heart rate twice a day(Unit :beats per minute)
Measured: Baseline; Up to 20 weeks
Measures of heart rhythm
Investigators will measure the heart rhythm twice a day
Measured: Baseline; Up to 20 weeks
Measures of blood pressure
Investigators will measure the blood pressure twice a day(Units :mmHg)
Measured: Baseline; Up to 20 weeks
Measures of central venous pressure
Investigators will measure the central venous pressure(Unit :cmH2O)
Measured: Up to 20 weeks
Measures of liquid volume
Investigators will measure the liquid volume each day after surgery
Measured: Up to 20 weeks
Measures of creatinine
Investigators will measure the creatinine(Unit :umol/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of blood urea nitrogen
Investigators will measure the blood urea nitrogen(Unit :mmol/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of glutamic oxalacetic transaminase
Investigators will measure the glutamic oxalacetic transaminase(Unit :U/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of glutamic pyruvate transaminase
Investigators will measure the glutamic pyruvate transaminase(Unit :U/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of total bilirubin
Investigators will measure the total bilirubin(Unit :umol/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of N-terminal pro B-type natriuretic peptide
Investigators will measure the N-terminal pro B-type natriuretic peptide(Unit :pg/ml)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of endothelin
Investigators will measure the endothelin(Unit :ng/L)
Measured: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start5 Jul 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Tibet Kang Zhe Pharmaceutical Technology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Zhang Yajuan, MD,PhD, Principal investigator, China National Center for Cardiovascular DiseaseDuan Yabing, MD, Principal investigator, China National Center for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207295
- Sponsor's protocol ID
- 2017-898
- Status last verified
- Jun 2017
- First submitted
- 28 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Consent for sharing of non identifiable study data for regulatory authorities
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Single-Center Clinical Study of the Efficacy and Safety of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
- ClinicalTrials.gov ID
- NCT03207295
- Acronym / sponsor ID
- 2017-898
- Keywords
- Nesiritide, Total Cavo-Pulmonary Connection, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Tibet Kang Zhe Pharmaceutical Technology Co., Ltd
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass. Investigators seek to determine whether nesiritide would improve the early postoperative course after total cavo-pulmonary connection surgery in children.
Detailed description
Objective: This study aims to evaluate the efficacy and safety of nesiritide after total cavo-pulmonary connection surgery in children. Investigators hypothesized that compared with placebo, patients assigned to receive nesiritide will improve early postoperative outcomes. Study design: The study is a a single-center, randomized, single-blinded, placebo-controlled, two-arm parallel-group clinical trial, patients undergoing total cavo-pulmonary connection surgery are assigned to receive nesiritide or placebo. A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission. The primary outcome is days of chest drainage. Secondary outcomes included days of hospitalization measures of cardiovascular function, renal function, and adverse events and neurohumoral. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive study drug. All the participants will be followed up during hospitalization .
Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-Nesiritide | Experimental | Drug: NesiritideA standard dose of Nesiritide(0.001ug/kg/min) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children |
| Control-Normal saline | Placebo comparator | Drug: Normal salineNormal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Elective general anesthesia down Fontan surgery patients, postoperative retention of patients with thoracic drainage tube
- Age ≤ 14 years old between hospitalized patients, men and women are not limited
- Postoperative hospital stay> 7 days
- Patients or guardians voluntarily signed informed consent
Key exclusion criteria (11 listed)
- Before the group had serious head trauma need hospitalization or brain surgery patients
- Who received organ transplants
- Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs
- Preoperative cardiogenic shock or hypotension difficult to correct the patient
- Preoperative patients with active arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NesiritideA standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission | Drug | Intervention-Nesiritide |
| Normal salineNormal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children | Drug | Control-Normal saline |
Primary outcome
Days of chest drainage
Time frame: Up to 18 weeks
Investigators will measure the daily chest drainage flow before discharge
14 secondary outcomes
Days of hospitalization after surgery
Time frame: Up to 20 weeks
Postoperative early survival
Time frame: The 30th day after surgery
Measures of heart rate
Time frame: Baseline; Up to 20 weeks
Measures of heart rhythm
Time frame: Baseline; Up to 20 weeks
Measures of blood pressure
Time frame: Baseline; Up to 20 weeks
Measures of central venous pressure
Time frame: Up to 20 weeks
Measures of liquid volume
Time frame: Up to 20 weeks
Measures of creatinine
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of blood urea nitrogen
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of glutamic oxalacetic transaminase
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of glutamic pyruvate transaminase
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of total bilirubin
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of N-terminal pro B-type natriuretic peptide
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of endothelin
Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Undecided. Consent for sharing of non identifiable study data for regulatory authorities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Yajuan, MD,PhD principal investigator
China National Center for Cardiovascular Disease
Duan Yabing, MD principal investigator
China National Center for Cardiovascular Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nesiritide and Normal saline in people with Congenital Heart Disease and Total Cavo-pulmonary Connection, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Jun, MD,PhD (13701025206, yanjun.1112@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of chest drainage (time frame: Up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.