DopamineDOPHUMANNCT04753008
Respiratory Effects of Dopamine in the Perioperative Care
A study testing Dopamine administration in people with Dopamine and Bronchodilation, run by Szeged University at 1 site in Hungary.
Trial summary
Dopamine is frequently used as an inotropic drug to elevate cardiac output. In addition to the beneficial cardiac effect of this drug, the few previous studies addressing its ability to alter the airway tone reported controversial results. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dopamine, Bronchodilation, Heart
- What is being tested?
- Dopamine administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 13 Dec 2010to 31 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardial surgery patients undergoing cardiopulmonary bypass procedures
Who cannot join
- Chronic respiratory diseases, elderly (>80 years)
Trial locations and contacts
1 site in 1 country.
About this study
Dopamine is frequently used as an inotropic drug to elevate cardiac output. In addition to the beneficial cardiac effect of this drug, the few previous studies addressing its ability to alter the airway tone reported controversial results.
Thus, the investigators aimed at clarifying the potential of dopamine to alter gas exchange outcomes and the airway tone in patients undergoing cardiac surgeries with cardiopulmonary bypass.
Read more
Blood gas parameters, airway resistance, tissue damping and tissue elastance will be measured in the patients before the CPB, immediately after CPB, and 5 min after administration of dopamine (3 mcg/kg/min).
The importance of the research is to reveal whether the beneficial mechanical changes after dopamine administrations are associated with improvements in gas exchange outcomes. Clarification of this research question have scientific relevance and may also improves patient outcomes.
- Conditions
- Dopamine, Bronchodilation, Heart, Surgery, Functional Disturbance
- Being tested
- Dopamine administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dopamine administrationDrug
Administration of dopamine (3 mcg/kg/min) as part of cardiac support therapy after the cardiopulmonary bypass. Administration of dopamine is a subject of clinical decision based on the cardiovascular status of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Dopamine group | Experimental | Cardiac surgery patients receiving dopamine to support their cardiac function (as part of the routine post-operative care). Receives: Drug: Dopamine administration |
| Control group | No intervention | Cardiac surgery patients receiving no positive inotrope drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen partial pressure (PaO2)
Partial pressure of oxygen in the blood sample assessed by a blood gas analyser.
Measured: 5 min after administration of dopamine
Arterial carbon dioxide partial pressure (PaCO2)
Partial pressure of carbon dioxide in the blood sample assessed by a blood gas analyser.
Measured: 5 min after administration of dopamine
Lung mechanics
Airway resistance, lung tissue damping and lung tissue elastance obtained by forced oscillation technique.
Measured: 5 min after administration of dopamine
Secondary outcomes (2)
Capnography
Time capnography to obtain phase 3 and phase 2 slopes.
Measured: 5 min after administration of dopamine
Intrapulmonary shunt
Intrapulmonary shunt obtained by the Berggren shunt equation from arterial and central venous blood samples.
Measured: 5 min after administration of dopamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start13 Dec 2010
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DopamineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753008
- Sponsor's protocol ID
- DOPHUMAN
- Acronym
- DOPHUMAN
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Effects of Dopamine in the Perioperative Care
- ClinicalTrials.gov ID
- NCT04753008
- Acronym / sponsor ID
- DOPHUMAN / DOPHUMAN
- Conditions
- Dopamine, Bronchodilation, Heart, Surgery, Functional Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 13 Dec 2010 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Feb 2021 (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.
Dopamine is frequently used as an inotropic drug to elevate cardiac output. In addition to the beneficial cardiac effect of this drug, the few previous studies addressing its ability to alter the airway tone reported controversial results.
Thus, the investigators aimed at clarifying the potential of dopamine to alter gas exchange outcomes and the airway tone in patients undergoing cardiac surgeries with cardiopulmonary bypass.
Blood gas parameters, airway resistance, tissue damping and tissue elastance will be measured in the patients before the CPB, immediately after CPB, and 5 min after administration of dopamine (3 mcg/kg/min).
The importance of the research is to reveal whether the beneficial mechanical changes after dopamine administrations are associated with improvements in gas exchange outcomes. Clarification of this research question have scientific relevance and may also improves patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dopamine group | Experimental | Drug: Dopamine administrationCardiac surgery patients receiving dopamine to support their cardiac function (as part of the routine post-operative care). |
| Control group | No intervention | –Cardiac surgery patients receiving no positive inotrope drug. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardial surgery patients undergoing cardiopulmonary bypass procedures
Key exclusion criteria (1 listed)
- Chronic respiratory diseases, elderly (>80 years)
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 |
|---|---|---|
| Dopamine administrationAdministration of dopamine (3 mcg/kg/min) as part of cardiac support therapy after the cardiopulmonary bypass. Administration of dopamine is a subject of clinical decision based on the cardiovascular status of the patients. | Drug | Dopamine group |
Primary outcome
Arterial oxygen partial pressure (PaO2)
Time frame: 5 min after administration of dopamine
Partial pressure of oxygen in the blood sample assessed by a blood gas analyser.
Arterial carbon dioxide partial pressure (PaCO2)
Time frame: 5 min after administration of dopamine
Partial pressure of carbon dioxide in the blood sample assessed by a blood gas analyser.
Lung mechanics
Time frame: 5 min after administration of dopamine
Airway resistance, lung tissue damping and lung tissue elastance obtained by forced oscillation technique.
2 secondary outcomes
Capnography
Time frame: 5 min after administration of dopamine
Intrapulmonary shunt
Time frame: 5 min after administration of dopamine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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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 study testing Dopamine administration in people with Dopamine and Bronchodilation, run by Szeged University at 1 site in Hungary.
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 1 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 12 Feb 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 Hungary. 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.
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?
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?
Arterial oxygen partial pressure (PaO2) (time frame: 5 min after administration of dopamine). The study lists 3 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 12 Feb 2021.