NCT01597427

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

2.1 years

First QC Date

May 8, 2012

Last Update Submit

May 10, 2012

Conditions

Anesthesia

Keywords

ClonidineHypertension PulmonaryCardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Reduction pulmonary artery pressure

    Assessed four times: before (T0) administration of 2 μg·kg-1 of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (T1), immediately after ECC (T2), and 10 minutes after the injection of protamine (T3).

    During intraoperative (hours)

Secondary Outcomes (2)

  • Doses of Dobutamine

    During intraoperative (hours)

  • Doses of Sodium nitroprusside

    During intraoperative (hours)

Study Arms (2)

Clonidine

SHAM COMPARATOR

Administration of 2 μg/kg of intravenous clonidine.

Drug: Clonidine

Placebo

PLACEBO COMPARATOR

Injection of placebo solution.

Drug: Placebo

Interventions

ClonidineDRUG

Administration of 2 μg/kg of intravenous clonidine

Clonidine
PlaceboDRUG

Injection of placebo solution.

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luiz Fernando dos Reis Falcao

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luiz Fernando R Falcao, Ph.D.

    Federal University of São Paulo

    STUDY CHAIR

  • Benedito B Joao, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 14, 2012

Study Start

March 1, 2009

Primary Completion

April 1, 2011

Study Completion

March 1, 2012

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

BR(1)