Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass

April 28, 2016 updated by: Yonsei University
This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

72

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patinets > 20 years old who are scheduled for elective on-pump cardiac surgery

Description

Inclusion Criteria:

  • age > 20 yrs, scheduled for elective on-pump cardiac surgery

Exclusion Criteria:

  • known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate > 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate

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

Cohorts and Interventions

Group / Cohort
SPP
Patients undergoing cardiac surgery with perioperative monitoring of Skin Perfusion Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of skin perfusion pressure
Time Frame: From post induction to 6 hours
From post induction to 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of arterial lactate level
Time Frame: From post induction to 48 hours
From post induction to 48 hours

Collaborators and Investigators

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

Sponsor

Yonsei 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

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2014-0070

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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