Clinical trial NCT01586585: Back to Functional Life Following Cardiac Surgery
Official title: Patient Rehabilitation Post Cardiac Surgery Based on Their Pre-op Status
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiac Study Patients
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgery patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of time taken to the patient to get back to functional life
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants with Adverse Events stratified by Frailty index
timeFrame: 3 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Cramel Medical Center
name: Yaron Barac, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: