Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Respiratory Effects of Dopamine in the Perioperative Care (DOPHUMAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753008
Recruitment Status : Active, not recruiting
First Posted : February 12, 2021
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Szeged University

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.


Condition or disease Intervention/treatment Phase
Dopamine Bronchodilation Heart Surgery Functional Disturbance Drug: Dopamine administration Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Respiratory Effects of Dopamine in the Perioperative Care
Actual Study Start Date : December 13, 2010
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Lung mechanics [ Time Frame: 5 min after administration of dopamine ]
    Airway resistance, lung tissue damping and lung tissue elastance obtained by forced oscillation technique.


Secondary Outcome Measures :
  1. Capnography [ Time Frame: 5 min after administration of dopamine ]
    Time capnography to obtain phase 3 and phase 2 slopes.

  2. Intrapulmonary shunt [ Time Frame: 5 min after administration of dopamine ]
    Intrapulmonary shunt obtained by the Berggren shunt equation from arterial and central venous blood samples.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardial surgery patients undergoing cardiopulmonary bypass procedures

Exclusion Criteria:

  • Chronic respiratory diseases, elderly (>80 years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753008


Locations
Layout table for location information
Hungary
Barna Babik
Szeged, Hungary, 6725
Sponsors and Collaborators
Szeged University
Layout table for additonal information
Responsible Party: Szeged University
ClinicalTrials.gov Identifier: NCT04753008    
Other Study ID Numbers: DOPHUMAN
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents