Back to Functional Life Following Cardiac Surgery

Withdrawn

• Conditions: Cardiac Study Patients

• Registration Number: NCT01586585
• Lead Sponsor: Carmel Medical Center

Brief Summary

The investigators will monitor cardiac patients rehabilitation post op upon their pre op status.

Detailed Description

In this work we will try to monitor the patients for a longer period, starting from their hospitalization period through their rehabilitation period up to 18 months post their discharge from the hospital.

Many studies tried to evaluate different ways to predict postoperative complications following cardiac surgery, patient's survival, rehabilitation rate and duration. Today, following these studies doctors use different methods to evaluate these parameters. The Society of Thoracic Surgeons mortality risk score (STS) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system are the two most frequently used risk profile systems within the United States and Europe. The STS score is comprised of over 40 clinical parameters, whereas the EuroSCORE involves 18 clinical characteristics that comprises three categories, each weighted accordingly. Studies published recently suggest that a combination of a new frailty score and the traditional scoring systems may facilitate a more accurate risk scoring in elderly high-risk patients scheduled for conventional cardiac surgery or trans-catheter aortic valve replacement.

In this study we will try to evaluate the contribution of using a frailty score index in addition to the EuroSCORE evaluation in patients≥50 years of age, in prediction of postoperative complications following cardiac surgery.

Study Timeline

• Study First Submitted: 2012-04-22
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-27
• Study Start: 2012-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-23
• Last Update Posted: 2013-10-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients undergoing cardiothoracic surgery in the Cardiothoracic Surgery Department at Carmel Medical center, Haifa, Israel, between: 1.5.12-28.2.14.
2. Patients ≥ 50 years of age
3. Informed consent from each participant that can understand, read and sign the informed consent form.

Exclusion Criteria

1. Emergent surgery, defined as a surgery for which there should be no delay due to ongoing refractory cardiac compromise.
2. Clinical instability, defined as active coronary ischemia, decompensated heart failure not yet stabilized, or any acute process causing significant symptoms or abnormal vital signs.
3. Severe neuropsychiatric condition causing inability to cooperate with the study procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Length of time taken to the patient to get back to functional life	3 years	The back to functional life period will be estimated using questionnaires that will be filled by the patient before the operation and in intervals after the operation

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events stratified by Frailty index	3 years	The patients will go through different tests in order to estimate their fragility index, their post op complications will be monitored, and we will try to find association between the frailty index and severity and number of complications

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel