Respiratory Effects of Dopamine in the Perioperative Care

Surgery Clinical Trial

— DOPHUMAN  

Official title:

Respiratory Effects of Dopamine in the Perioperative Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04753008
• Other study ID #: DOPHUMAN
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Bronchodilation
• Dopamine
• Functional Disturbance
• Heart
• Surgery

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