Reduction of Pulmonary Artery Pressure in Patients Subjected to Cardiac Surgery

NCT ID: NCT01597427

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective, clinical-interventionist, randomized, and double-blind study. Patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. Mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (T0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after extracorporeal circulation (T2), and 10 minutes after the injection of protamine (T3).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clonidine

Administration of 2 μg/kg of intravenous clonidine.

Group Type SHAM_COMPARATOR

Clonidine

Intervention Type DRUG

Administration of 2 μg/kg of intravenous clonidine

Placebo

Injection of placebo solution.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Injection of placebo solution.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clonidine

Administration of 2 μg/kg of intravenous clonidine

Intervention Type DRUG

Placebo

Injection of placebo solution.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signing an informed consent form,
* Aged 18 to 80 years
* Pulmonary hypertension due to left heart disease,
* Physical status 2 or 3 according to the classification system of the American Society of Anesthesiologists,
* Subjected to cardiac circulation with extracorporeal circulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luiz Fernando dos Reis Falcao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luiz Fernando R Falcao, Ph.D.

Role: STUDY_CHAIR

Federal University of São Paulo

Benedito B Joao, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Luiz Fernando dos Reis Falcao

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNIFESP-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pilot - Peri-operative Beta Blockade
NCT02746575 COMPLETED PHASE4
Beta-blockers in i-PAH
NCT01246037 UNKNOWN PHASE1/PHASE2
Inhaled Milrinone in Cardiac Surgery
NCT01725776 COMPLETED PHASE2