NCT03013062

Brief Summary

Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the three formulae

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

January 2, 2017

Last Update Submit

June 1, 2017

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Pulmonary acceleration time

    Till post-extubation, an average of 2 days

Study Arms (1)

WITH PULMONARY HYPERTENSION

It is defined as MPAP \> 25 mm Hg at rest or \>30 mm Hg during exercise with PVR \> 3 wood units and PCWP \< 15 mm Hg.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\> 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

You may qualify if:

  • years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

You may not qualify if:

  • Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • GANESH KUMAR M

    PGIMER, CHANDIGARH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GANESH KUMAR M, MD

CONTACT

8968170779mganeshkumar19@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow resident, Department of anesthesia and intensive care, Principal investigator

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 6, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

IN(1)