Low Cardiac Output SyndromePhase 3NCT03823781
Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants
A Phase 3 study testing Milrinone and Normal saline in people with Low Cardiac Output Syndrome and Cardiac Surgical Procedures, run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Low Cardiac Output Syndrome, Cardiac Surgical Procedures, Infant
- What is being tested?
- Milrinone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- Feb 2019to Jul 2021
- Phase
- Phase 3
- 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age younger than 12 months
- Without pre-operative low cardiac output syndrome
- Bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass
- Informed consent obtained from each participant's parent or guardian
Who cannot join
- A body weight <2 kg
- Prematurity (birth <36 weeks postconceptual age)
- Renal dysfunction ( Creatinine>1.5mg/dL 48 hours before surgery)
- Low cardiac output syndrome or hypotension on arrival to ICU from OR
- Cardiopulmonary resuscitation before surgery
- Platelet count<80,000/mm3 before surgery
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- Left ventricular outflow tract obstruction before surgery
- Ventricular arrhythmia before surgery
- Without femoral artery catheter before arriving in the ICU
- Consent was withdrawn by participants' parent or guardian.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
Jihong Huang, MD, PhD, +8618930830766, huangjihong@scmc.com.cn
Chunxiang Li, MD, +8618916611383, lichunxiang@scmc.com.cn
About this study
Official title: Prophylactic Milrinone Infusion for the Prevention Low Cardiac Output Syndrome After Corrective Surgery for Congenital Heart Disease in Infants: A Randomized, Multi-center, Double-blinded, Placebo-controlled Study
This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.
- Being tested
- Milrinone, Normal saline
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilrinoneDrug
Also called Milrinone Lactate
The study intervention is an intravenous infusion of milrinone or placebo.
Normal salineDrug
Also called Normal Saline 0.9% Infusion Solution Bag
The study intervention is an intravenous infusion of milrinone or placebo.
| Study group | Role | What they receive |
|---|---|---|
| milrinone | Experimental | milrinone milrinone will be administered intravenously at a rate of 0.75ug/kg/min for 35 hours, and baseline catecholamines will be administered at the discretion of the physician. Receives: Drug: Milrinone |
| normal saline | Placebo comparator | placebo placebo (normal saline) will be administered intravenously for 35 hours, and baseline catecholamines will be administered at the discretion of the physician. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants died within 30 days postoperatively
Measured: up to 30 days postoperatively
Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug
Low cardiac output syndrome was defined as the following: clinical signs or symptoms (eg, tachycardia, oliguria, poor perfusion, or cardiac arrest) with or without a widened arterial-mixed venous oxygen saturation difference or metabolic acidosis; mechanical support of the circulation (eg, extracorporeal life support, ventricular assist device), a cardiac index determined by Pulse indicator continuous cardiac output (PiCCO) of <2.2 L/min/m2
Measured: 36 hours after initiation of study drug
Secondary outcomes (9)
Number of participants developed low cardiac output syndrome in the interval between 36 hours after initiation of study drug and the final Follow up. Cardiac index will be determined by Doppler echocardiography
Measured: up to 30 days postoperatively
Change in Vasoactive Inotrope Score.
Vasoactive Inotrope Score=100*Epinephrine dose (ug/kg/min)+100*Norepinephrine dose (ug/kg/min)+10*Dopamine dose (ug/kg/min)+10*Dobutamine dose (ug/kg/min) +10,000*Vasopressin dose (units/kg/min) +10*Milrinone dose (ug/kg/min)
Measured: 36 hours after initiation of study drug
Length of intensive care stay.
Length of intensive care stay will be calculated from date of ICU admission to date of ICU discharge
Measured: up to 30 days postoperatively or until ICU discharge.
Length of hospital stay.
Length of hospital stay will be calculated from date of hospital admission to date of hospital discharge
Measured: up to 30 days postoperatively or until hospital discharge
Duration of mechanical ventilation.
Duration of mechanical ventilation will be calculated from date and time of ICU admission to date and time of extubation
Measured: up to 30 days postoperatively or until extubation
Number of participants with improvement of ventriculoarterial coupling
ventriculoarterial coupling improvement will be assessed by means of ventriculoarterial coupling values shift closer to 1. ventriculoarterial coupling will be obtained as : (1-EF)/EF
Measured: 36 hours after initiation of study drug
Number of participants requiring mechanical circulatory support.
eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device
Measured: up to 30 days postoperatively
Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.
Cerebral and abdominal regional tissue oxygenation will be monitored
Measured: 36 hours after initiation of study drug
Number of participants with treatment-related adverse events
Treatment-related adverse events will be evaluated by sponsor's drug safety surveillance reviewer
Measured: 36 hours after initiation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Cardiac Output SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huiwen Chen, MD, PhD, Study director, Department of clinical research, Shanghai children's medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823781
- Sponsor's protocol ID
- SCMCIRB-K2018105
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Milrinone Infusion for the Prevention Low Cardiac Output Syndrome After Corrective Surgery for Congenital Heart Disease in Infants: A Randomized, Multi-center, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03823781
- Acronym / sponsor ID
- SCMCIRB-K2018105
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 30 Jan 2019 (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.
This randomized, multi-center, double-blinded, placebo-controlled study is designed to evaluate the efficacy and safety of milrinone compared with placebo in participants after corrective surgery for congenital heart disease. Participants will be randomized in a 1:1 ratio within 90 minutes after arriving in the intensive care unit (ICU), to receive either intravenous milrinone or placebo for 36 hours. Participants will be stratified according Vasoactive Inotrope Score after arriving in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milrinone | Experimental | Drug: Milrinonemilrinone milrinone will be administered intravenously at a rate of 0.75ug/kg/min for 35 hours, and baseline catecholamines will be administered at the discretion of the physician. |
| normal saline | Placebo comparator | Drug: Normal salineplacebo placebo (normal saline) will be administered intravenously for 35 hours, and baseline catecholamines will be administered at the discretion of the physician. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age younger than 12 months
- Without pre-operative low cardiac output syndrome
- Bi-ventricular repair of congenital heart disease involving cardiopulmonary bypass
- Informed consent obtained from each participant's parent or guardian
Key exclusion criteria (10 listed)
- A body weight <2 kg
- Prematurity (birth <36 weeks postconceptual age)
- Renal dysfunction ( Creatinine>1.5mg/dL 48 hours before surgery)
- Low cardiac output syndrome or hypotension on arrival to ICU from OR
- Cardiopulmonary resuscitation before surgery
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 |
|---|---|---|
| MilrinoneAlso: Milrinone LactateThe study intervention is an intravenous infusion of milrinone or placebo. | Drug | milrinone |
| Normal salineAlso: Normal Saline 0.9% Infusion Solution BagThe study intervention is an intravenous infusion of milrinone or placebo. | Drug | normal saline |
Primary outcome
Number of participants died within 30 days postoperatively
Time frame: up to 30 days postoperatively
Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug
Time frame: 36 hours after initiation of study drug
Low cardiac output syndrome was defined as the following: clinical signs or symptoms (eg, tachycardia, oliguria, poor perfusion, or cardiac arrest) with or without a widened arterial-mixed venous oxygen saturation difference or metabolic acidosis; mechanical support of the circulation (eg, extracorporeal life support, ventricular assist device), a cardiac index determined by Pulse indicator continuous cardiac output (PiCCO) of <2.2 L/min/m2
9 secondary outcomes
Number of participants developed low cardiac output syndrome in the interval between 36 hours after initiation of study drug and the final Follow up. Cardiac index will be determined by Doppler echocardiography
Time frame: up to 30 days postoperatively
Change in Vasoactive Inotrope Score.
Time frame: 36 hours after initiation of study drug
Length of intensive care stay.
Time frame: up to 30 days postoperatively or until ICU discharge.
Length of hospital stay.
Time frame: up to 30 days postoperatively or until hospital discharge
Duration of mechanical ventilation.
Time frame: up to 30 days postoperatively or until extubation
Number of participants with improvement of ventriculoarterial coupling
Time frame: 36 hours after initiation of study drug
Number of participants requiring mechanical circulatory support.
Time frame: up to 30 days postoperatively
Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline.
Time frame: 36 hours after initiation of study drug
Number of participants with treatment-related adverse events
Time frame: 36 hours after initiation of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Huiwen Chen, MD, PhD study director
Department of clinical research, Shanghai children's medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Milrinone and Normal saline in people with Low Cardiac Output Syndrome and Cardiac Surgical Procedures, run by Shanghai Children's Medical Center 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 10 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 30 Jan 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jihong Huang, MD, PhD (+8618930830766, huangjihong@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants died within 30 days postoperatively (time frame: up to 30 days postoperatively). The study lists 2 primary outcomes in all. 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 30 Jan 2019.