ChiCTR2200057463 版本V1.2 版本创建时间2024/06/11 09:45:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200057463 

最近更新日期：

Date of Last Refreshed on：

 2023-07-23 20:56:22 

注册时间：

Date of Registration：

 2022-03-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

Public title：

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

Scientific title：

Effect of prehabilitation-related dietary protein intake on quality of recovery after elective cardiac surgery: a randomized controlled trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Helen Hoi Ting Cheung  

研究负责人：

Professor Anna Lee 

Applicant：

Helen Hoi Ting Cheung  

Study leader：

Professor Anna Lee 

申请注册联系人电话：

Applicant telephone：

 +852 35052087

研究负责人电话：

Study leader's
telephone：

+852 35052739

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 helenhtcheung@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 annalee@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

研究负责人通讯地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Applicant address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Study leader's address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021.703

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committe

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-02-22 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

Primary sponsor：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Primary sponsor's address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Hong Kong

省(直辖市)：

Hong Kong

市(区县)：

Country：

Hong Kong

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

The Chinese University of Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

The Chinese University of Hong Kong

经费或物资来源：

department funding

Source(s) of funding：

department funding

研究疾病：

preoperative protein-calorie malnutrition  

Target disease：

preoperative protein-calorie malnutrition

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To determine the potential for dietitian guided change in preoperative dietary protein intake levels in malnourished patients scheduled for elective cardiac surgery undergoing nutritional prehabilitation. 2. To evaluate the effect of high-quality dietary protein intake on the quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation. 3. To evaluate the effect of nutritional prehabilitation on the length of postoperative stay in malnourished patients undergoing elective cardiac surgery. 4. To determine the synergistic effect of preoperative dietary protein intake and physical activity on quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation.  

Objectives of Study：

1. To determine the potential for dietitian guided change in preoperative dietary protein intake levels in malnourished patients scheduled for elective cardiac surgery undergoing nutritional prehabilitation. 2. To evaluate the effect of high-quality dietary protein intake on the quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation. 3. To evaluate the effect of nutritional prehabilitation on the length of postoperative stay in malnourished patients undergoing elective cardiac surgery. 4. To determine the synergistic effect of preoperative dietary protein intake and physical activity on quality of recovery after elective cardiac surgery in malnourished patients undergoing nutritional prehabilitation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Adults (no age restriction) undergoing elective or non-emergent major to ultra-major cardiac surgery (CABG, valve surgery or combined)
2. MUST>0 or FFMI<17 for men or FFMI<15 for women or SMI<7 for men or SMI<5.7 for women

Patients on the elective cardiac surgery waiting list are routinely assessed the Perioperative Medicine Clinic several weeks before the scheduled operation date. After written informed consent, patients will complete the MUST questionnaire and undertake a body composition test using a bioelectrical impedance analysis device (InBody 270, InBodyUSA, Cerritos, CA) to measure FFMI and SMI for study eligibility determination.

Inclusion criteria

1. Adults (no age restriction) undergoing elective or non-emergent major to ultra-major cardiac surgery (CABG, valve surgery or combined)
2. MUST>0 or FFMI<17 for men or FFMI<15 for women or SMI<7 for men or SMI<5.7 for women

Patients on the elective cardiac surgery waiting list are routinely assessed the Perioperative Medicine Clinic several weeks before the scheduled operation date. After written informed consent, patients will complete the MUST questionnaire and undertake a body composition test using a bioelectrical impedance analysis device (InBody 270, InBodyUSA, Cerritos, CA) to measure FFMI and SMI for study eligibility determination.

排除标准：

1. Redo or emergency cardiac surgery
2. Major comorbidities precluding surgery, are mentally incompetent, any current disorder impairing accurate and objective completion of the malnutrition assessment and questionnaires, or are unable to understand Chinese or English.
3. CKD not on dialysis requiring low protein diet, advanced stage CKD or end-stage renal disease on dialysis with protein requirements of 1.0 to 1.2 g/kg body weight/day will be excluded [38]
4. Patients with liver diseases and at risk for hepatic encephalopathy
5. Physical limitations that would preclude regular attendance to outpatient nutritional prehabilitation sessions
6. Seen by a dietician in the last 6 months

Exclusion criteria：

1. Redo or emergency cardiac surgery
2. Major comorbidities precluding surgery, are mentally incompetent, any current disorder impairing accurate and objective completion of the malnutrition assessment and questionnaires, or are unable to understand Chinese or English.
3. CKD not on dialysis requiring low protein diet, advanced stage CKD or end-stage renal disease on dialysis with protein requirements of 1.0 to 1.2 g/kg body weight/day will be excluded [38]
4. Patients with liver diseases and at risk for hepatic encephalopathy
5. Physical limitations that would preclude regular attendance to outpatient nutritional prehabilitation sessions
6. Seen by a dietician in the last 6 months

研究实施时间：

Study execute time：

从 From 2022-09-01 00:00:00至 To 2025-08-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-01 00:00:00 至 To 2025-08-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 66

Group：

Intervention group

Sample size：

干预措施：

nutrition counseling and protein supplements

干预措施代码：

Intervention：

intervention

Intervention code：

组别：

Control group

样本量：

 66

Group：

Control group

Sample size：

干预措施：

current practice

干预措施代码：

Intervention：

control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 Prince of Wales Hospital 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

quality of recovery

指标类型：

主要指标

Outcome：

quality of recovery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Days (alive and) at home within 30 (DAH30) days after cardiac surgery

指标类型：

主要指标

Outcome：

Days (alive and) at home within 30 (DAH30) days after cardiac surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Disability-free survival at 30 after surgery

指标类型：

次要指标

Outcome：

Disability-free survival at 30 after surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Health-related quality of life

指标类型：

次要指标

Outcome：

Health-related quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Cardiac Postoperative Morbidity Survey (C-POM)

指标类型：

次要指标

Outcome：

Cardiac Postoperative Morbidity Survey (C-POM)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

not collecting

组织：

Sample Name：

not collecting

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

This is a single-center, pragmatic, two-armed, parallel, superiority, blinded randomized controlled trial. Participants will be randomly allocated to either nutritional prehabilitation or usual care (no nutritional prehabilitation) with 1:1 allocation. Block randomization with randomly selected block sizes will be performed.

Randomization Procedure (please state who generates the random number sequence and by what method)：

This is a single-center, pragmatic, two-armed, parallel, superiority, blinded randomized controlled trial. Participants will be randomly allocated to either nutritional prehabilitation or usual care (no nutritional prehabilitation) with 1:1 allocation. Block randomization with randomly selected block sizes will be performed.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

CUHK Research Data Repository -- Dataverse

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

CUHK Research Data Repository -- Dataverse

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

we are using REDCap for data collection and management.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

we are using REDCap for data collection and management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2022-03-13 03:19:55