Respiratory Effects of Dopamine in the Perioperative Care (DOPHUMAN)

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 Overview

• Status: Active, not recruiting
• Conditions: Surgery; Functional Disturbance; Dopamine; Bronchodilation; Heart
• Intervention / Treatment: Drug: Dopamine administration

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary, 6725
    • Barna Babik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cardial surgery patients undergoing cardiopulmonary bypass procedures

Exclusion Criteria:

• Chronic respiratory diseases, elderly (>80 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dopamine group; Cardiac surgery patients receiving dopamine to support their cardiac function (as part of the routine post-operative care).	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.
No Intervention: Control group; Cardiac surgery patients receiving no positive inotrope drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Lung mechanics	Airway resistance, lung tissue damping and lung tissue elastance obtained by forced oscillation technique.	5 min after administration of dopamine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capnography	Time capnography to obtain phase 3 and phase 2 slopes.	5 min after administration of dopamine
Intrapulmonary shunt	Intrapulmonary shunt obtained by the Berggren shunt equation from arterial and central venous blood samples.	5 min after administration of dopamine

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2010
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Dopamine
• Other Study ID Numbers: DOPHUMAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No