Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?

Disorder; Heart, Functional, Postoperative, Cardiac Surgery Clinical Trial

Official title:

Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02212509
• Other study ID #: 201203074RIC
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2014
• Last updated: August 6, 2014
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The aims of the cohort study is to describe the rates of 30-day surgical complication, functional decline, frailty and one-year mortality for patients experienced cardiac surgery and to delineate the trajectory of functional capacity 1 year after surgery for the patients. It also will test whether the trajectory of functional varied significantly according to delirium status and its type over the follow-up period and examine the patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery as well as evaluate whether activity levels, dietary diversity, and depressive symptoms at 3,6, and 12 months affect patient outcome.

Description:

In Taiwan, 54.2% of cardiac surgical procedures in 2010 were performed on older patients (≧65 years) with higher rates of surgical complications, functional decline, and even death reported. Despite the large number of older patients undergoing cardiac surgery with the goal of improving functional capacity, the literature in this area is limited. Specifically, there is little information about the functional outcomes 1 year after cardiac surgery for older patients.

A prospective, longitudinal cohort study will be conducted to assess and follow patients aged 65 years and older who undergoing elective or non-elective cardiac surgery for one year after surgery. All patients on the cardio-surgical wards of 5A, 5B, and 5CVI at National Taiwan University Hospital will be screened for eligibility. Every patient ≧65 years admitted for cardiac surgery will be approached and invited to participate. This cohort study aims to 1)describe the rates of 30-day surgical complication, functional decline, frailty, and one-year mortality for older patients underwent cardiac surgery; 2) delineate the rajectory of functional capacity 1 year after surgery for these patients; 3) test whether the trajectory of functional capacity varied significantly according to delirium status and its type over the one-year follow-up period; 4)examine patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery; and 5) evaluate hether activity levels, dietary diversity, and depressive symptoms at 3, 6, and 12 months affect patient outcomes. Estimated 236 participants will be enrolled to ensure the power of study.

Data will be analyzed using the SAS package. The Generalized Estimating Equation (GEE) will be performed to identify the risk factors and to delineate the trajectory of functional capacity 1 year after cardiac surgery for older patients. The findings will add to the development of nursing intervention program to promote functional recovery for older patients after cardiac surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients over 20 years old

• admitted for elective or non-elective cardiac surgery

Exclusion Criteria:

• incapable of verbal communication

• sensory impairment

• intubation or respiratory isolation

• patients with critical condition or coma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 days surgical complication		30 days after surgery	No
Primary	physical activity function		admission and 1 year after surgery	No
Secondary	mortality		1 year after surgery	No