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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04753008
Other study ID # DOPHUMAN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 13, 2010
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Szeged University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Cardial surgery patients undergoing cardiopulmonary bypass procedures Exclusion Criteria: - Chronic respiratory diseases, elderly (>80 years)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dopamine administration
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.

Locations

Country Name City State
Hungary Barna Babik Szeged

Sponsors (1)

Lead Sponsor Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial oxygen partial pressure (PaO2) Partial pressure of oxygen in the blood sample assessed by a blood gas analyser. 5 min after administration of dopamine
Primary Arterial carbon dioxide partial pressure (PaCO2) Partial pressure of carbon dioxide in the blood sample assessed by a blood gas analyser. 5 min after administration of dopamine
Primary Lung mechanics Airway resistance, lung tissue damping and lung tissue elastance obtained by forced oscillation technique. 5 min after administration of dopamine
Secondary Capnography Time capnography to obtain phase 3 and phase 2 slopes. 5 min after administration of dopamine
Secondary Intrapulmonary shunt Intrapulmonary shunt obtained by the Berggren shunt equation from arterial and central venous blood samples. 5 min after administration of dopamine
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