AnesthesiaPhase 3NCT04536194
Dopamine Versus Norepinephrine Under General Anesthesia
A Phase 3 study testing norepinephrine and dopamine in people with Anesthesia and Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Anesthesia, Infant, Congenital Heart Disease
- What is being tested?
- norepinephrine and dopamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 30 Sep 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- undertake cardiac surgery for congenital heart disease
Who cannot join
- Aortic valve or aortic disease
- severe arrhythmia
- use of cardiovascular active drugs before anesthesia
- need to use a combination of different cardiovascular support drugs after anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.
Read the detailed description
After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.
- Conditions
- Anesthesia, Infant, Congenital Heart Disease, Hemodynamic Instability
- Being tested
- norepinephrine, dopamine
- Keywords
- norepinephrine, dopamine
- 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.
norepinephrineDrug
to treat hypotension under general anesthesia with norepinephrine
dopamineDrug
to treat hypotension under general anesthesia with dopamine
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine | Experimental | infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure Receives: Drug: norepinephrine |
| Dopamine | Active comparator | infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure Receives: Drug: dopamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of cardiac index
the differences of cardiac index between after and before the intervention (l/min/m2)
Measured: 20 minutes
Secondary outcomes (4)
changes of stroke volume index
the differences of stroke volume index between after and before the intervention (ml/m2)
Measured: 20 minutes
changes of systemic vascular resistance index
the differences of systemic vascular resistance index between after and before the intervention(dyne ∙ sec ∙ m2/cm5)
Measured: 20 minutes
changes of the maximal slope of systolic upstroke
the differences of the maximal slope of systolic upstroke between after and before the intervention(mmHg/ms)
Measured: 20 minutes
changes of heart rate
the differences of heart rate between after and before the intervention (bpm)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start10 Oct 2020
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijian Zhou, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536194
- Sponsor's protocol ID
- mzk-0003-2020
- Status last verified
- Oct 2021
- First submitted
- 21 Aug 2020
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yuan SM. Acute kidney injury after pediatric cardiac surgery. Pediatr Neonatol. 2019 Feb;60(1):3-11. doi: 10.1016/j.pedneo.2018.03.007. Epub 2018 Mar 30.
PubMed 29891225Foulon P, De Backer D. The hemodynamic effects of norepinephrine: far more than an increase in blood pressure! Ann Transl Med. 2018 Nov;6(Suppl 1):S25. doi: 10.21037/atm.2018.09.27. No abstract available.
PubMed 30613600Cavigelli-Brunner A, Hug MI, Dave H, Baenziger O, Buerki C, Bettex D, Cannizzaro V, Balmer C. Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. Pediatr Crit Care Med. 2018 Jul;19(7):619-625. doi: 10.1097/PCC.0000000000001533.
PubMed 29538053Saxena R, Durward A, Steeley S, Murdoch IA, Tibby SM. Predicting fluid responsiveness in 100 critically ill children: the effect of baseline contractility. Intensive Care Med. 2015 Dec;41(12):2161-9. doi: 10.1007/s00134-015-4075-8. Epub 2015 Sep 28.
PubMed 26415680Hamzaoui O, Jozwiak M, Geffriaud T, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Richard C, Teboul JL. Norepinephrine exerts an inotropic effect during the early phase of human septic shock. Br J Anaesth. 2018 Mar;120(3):517-524. doi: 10.1016/j.bja.2017.11.065. Epub 2017 Nov 21.
PubMed 29452808Favia I, Rizza A, Garisto C, Haiberger R, Di Chiara L, Romagnoli S, Ricci Z. Cardiac index assessment by the pressure recording analytical method in infants after paediatric cardiac surgery: a pilot retrospective study. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):919-923. doi: 10.1093/icvts/ivw251. Epub 2016 Aug 1.
PubMed 27481679Urbano J, Lopez J, Gonzalez R, Solana MJ, Fernandez SN, Bellon JM, Lopez-Herce J. Measurement of cardiac output in children by pressure-recording analytical method. Pediatr Cardiol. 2015 Feb;36(2):358-64. doi: 10.1007/s00246-014-1014-3. Epub 2014 Sep 2.
PubMed 25179459Garisto C, Favia I, Ricci Z, Romagnoli S, Haiberger R, Polito A, Cogo P. Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery. Paediatr Anaesth. 2015 Feb;25(2):143-9. doi: 10.1111/pan.12360. Epub 2014 Feb 3.
PubMed 24491036
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04536194
- Acronym / sponsor ID
- mzk-0003-2020
- Conditions
- Anesthesia, Infant, Congenital Heart Disease, Hemodynamic Instability
- Keywords
- norepinephrine, dopamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 2 Sep 2020 (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.
Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.
Detailed description
After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| norepinephrine | Experimental | Drug: norepinephrineinfusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure |
| Dopamine | Active comparator | Drug: dopamineinfusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- undertake cardiac surgery for congenital heart disease
Key exclusion criteria (4 listed)
- Aortic valve or aortic disease
- severe arrhythmia
- use of cardiovascular active drugs before anesthesia
- need to use a combination of different cardiovascular support drugs after anesthesia
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 |
|---|---|---|
| norepinephrineto treat hypotension under general anesthesia with norepinephrine | Drug | norepinephrine |
| dopamineto treat hypotension under general anesthesia with dopamine | Drug | Dopamine |
Primary outcome
changes of cardiac index
Time frame: 20 minutes
the differences of cardiac index between after and before the intervention (l/min/m2)
4 secondary outcomes
changes of stroke volume index
Time frame: 20 minutes
changes of systemic vascular resistance index
Time frame: 20 minutes
changes of the maximal slope of systolic upstroke
Time frame: 20 minutes
changes of heart rate
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 29891225Yuan SM. Acute kidney injury after pediatric cardiac surgery. Pediatr Neonatol. 2019 Feb;60(1):3-11. doi: 10.1016/j.pedneo.2018.03.007. Epub 2018 Mar 30.
- Background: PubMed 30613600Foulon P, De Backer D. The hemodynamic effects of norepinephrine: far more than an increase in blood pressure! Ann Transl Med. 2018 Nov;6(Suppl 1):S25. doi: 10.21037/atm.2018.09.27. No abstract available.
- Background: PubMed 29538053Cavigelli-Brunner A, Hug MI, Dave H, Baenziger O, Buerki C, Bettex D, Cannizzaro V, Balmer C. Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. Pediatr Crit Care Med. 2018 Jul;19(7):619-625. doi: 10.1097/PCC.0000000000001533.
- Background: PubMed 26415680Saxena R, Durward A, Steeley S, Murdoch IA, Tibby SM. Predicting fluid responsiveness in 100 critically ill children: the effect of baseline contractility. Intensive Care Med. 2015 Dec;41(12):2161-9. doi: 10.1007/s00134-015-4075-8. Epub 2015 Sep 28.
- Results publication: PubMed 29452808Hamzaoui O, Jozwiak M, Geffriaud T, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Richard C, Teboul JL. Norepinephrine exerts an inotropic effect during the early phase of human septic shock. Br J Anaesth. 2018 Mar;120(3):517-524. doi: 10.1016/j.bja.2017.11.065. Epub 2017 Nov 21.
- Results publication: PubMed 27481679Favia I, Rizza A, Garisto C, Haiberger R, Di Chiara L, Romagnoli S, Ricci Z. Cardiac index assessment by the pressure recording analytical method in infants after paediatric cardiac surgery: a pilot retrospective study. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):919-923. doi: 10.1093/icvts/ivw251. Epub 2016 Aug 1.
- Results publication: PubMed 25179459Urbano J, Lopez J, Gonzalez R, Solana MJ, Fernandez SN, Bellon JM, Lopez-Herce J. Measurement of cardiac output in children by pressure-recording analytical method. Pediatr Cardiol. 2015 Feb;36(2):358-64. doi: 10.1007/s00246-014-1014-3. Epub 2014 Sep 2.
- Results publication: PubMed 24491036Garisto C, Favia I, Ricci Z, Romagnoli S, Haiberger R, Polito A, Cogo P. Pressure recording analytical method and bioreactance for stroke volume index monitoring during pediatric cardiac surgery. Paediatr Anaesth. 2015 Feb;25(2):143-9. doi: 10.1111/pan.12360. Epub 2014 Feb 3.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 norepinephrine and dopamine in people with Anesthesia and Infant, run by Children's Hospital of Fudan University 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 22 Oct 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of cardiac index (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536194, which also lists 8 linked publications.
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 22 Oct 2021.