Respiratory Effects of Dopamine in the Perioperative Care

NCT04753008 | Unknown

• 1 other identifier: DOPHUMAN
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dopamine; Bronchodilation; Heart; Surgery; Functional Disturbance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Capnography

  5 min after administration of dopamine

• Intrapulmonary shunt

  5 min after administration of dopamine

Study Arms (2)

Dopamine group

EXPERIMENTAL

Cardiac surgery patients receiving dopamine to support their cardiac function (as part of the routine post-operative care).

Drug: Dopamine administration

Control group

NO INTERVENTION

Cardiac surgery patients receiving no positive inotrope drug.

Interventions

Dopamine administration DRUG

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.

Dopamine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardial surgery patients undergoing cardiopulmonary bypass procedures

You may not qualify if:

• Chronic respiratory diseases, elderly (\>80 years)

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

Barna Babik

Szeged, 6725, Hungary

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 12, 2021
• Study Start: December 13, 2010
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)