Respiratory Effects of Dopamine in the Perioperative Care (DOPHUMAN)

February 10, 2021 updated by: Szeged University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6725
        • Barna Babik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 5 min after administration of dopamine
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)
Time Frame: 5 min after administration of dopamine
Partial pressure of carbon dioxide in the blood sample assessed by a blood gas analyser.
5 min after administration of dopamine
Lung mechanics
Time Frame: 5 min after administration of dopamine
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 Frame: 5 min after administration of dopamine
Time capnography to obtain phase 3 and phase 2 slopes.
5 min after administration of dopamine
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.
5 min after administration of dopamine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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