Impact of poor nutrition on survival rates in patients with aortic dissection undergoing heart surgery
| ISRCTN | ISRCTN77727306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77727306 |
- Submission date
- 22/10/2024
- Registration date
- 25/10/2024
- Last edited
- 24/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Aortic dissection is a serious and potentially deadly condition where the inner layer of the aorta tears. This study looks at how a person's nutritional status, measured by the prognostic nutritional index (PNI), affects their chances of survival after surgery for type B aortic dissection (TBAD).
Who can participate?
The study included patients from the Aortic Dilatation Database of the First Affiliated Hospital of Naval Medical University. Patients with connective tissue diseases, traumatic dissection, secondary interventions, tumors, or incomplete data were not included.
What does the study involve?
Participants' medical records were reviewed to gather data. The study used various statistical models to analyze the relationship between PNI and patient outcomes after surgery.
What are the possible benefits and risks of participating?
The study aims to identify if PNI can predict survival rates, which could help doctors better assess and manage patients with TBAD. Since this is a retrospective study, there are no direct risks or benefits to the participants.
Where is the study run from?
The study is conducted at the First Affiliated Hospital of Naval Medical University in China.
When is the study starting and how long is it expected to run for?
The study reviewed data from January 2009 to July 2023.
Who is funding the study?
The study is funded by the National Natural Science Foundation of China, the Shanghai Emerging Cross Disciplinary Research Project, and the Research Project of Shanghai Municipal Health Commission.
Who is the main contact?
Prof. Jian Zhou: zhoujian1_3@163.com
Dr. Shuangshuang Li: lishuangshuangfy@163.com
Ms. Wen Li: daiyaliwen@hotmail.com
Contact information
Scientific
168 Changhai Road, Yangpu District
Shanghai
200433
China
 ORCID ID |
0000-0001-5887-2280 |
|---|---|
| Phone | +86 21-31161670/13611826460 |
| lishuangshuangfy@163.com |
Principal Investigator
168 Changhai Road, Yangpu District
Shanghai
200433
China
| Phone | +86 13818896067 |
|---|---|
| zhoujian1_3@163.com |
Public
225 Changhai Road, Yangpu District
Shanghai
200433
China
| Phone | +86 17821451628 |
|---|---|
| daiyaliwen@hotmail.com |
Study information
| Study design | Single-center observational retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Low prognostic nutritional index predicts case fatality of type B aortic dissection undergoing thoracic endovascular aortic repair |
| Study objectives | PNI could serve as a valuable marker for predicting 1-year all-cause mortality in patients with Type B aortic dissections. |
| Ethics approval(s) |
Approved 24/08/2020, Shanghai Changhai Hospital Ethics Committee (168 Changhai Road, Yangpu District, Shanghai, 200433, China; +86-21-31162338; changhaiec@126.com), ref: CHEC-Y2020-042 |
| Health condition(s) or problem(s) studied | Type B aortic dissection (TBAD) |
| Intervention | This retrospective study, conducted from January 2009 to July 2023, included 1,524 patients with aortic dissection who were treated with Thoracic endovascular aortic repair in the aortic dilation database of the First Affiliated Hospital of Naval Medical University. Among them, 563 patients were subsequently excluded from the study. Therefore, only 912 patients were included in the final analysis. Demographic variables, laboratory tests, intra-operative details and anatomical characteristics were extracted from medical records. BMI calculated as weight in kilograms divided by height in meters squared. Aortic dissection was classified into acute (1–14 days), sub-acute (15–90 days), or chronic (>90 days) stages according to “2014 ESC guidelines on the diagnosis and treatment of aortic diseases”. Blood samples were taken from all patients upon admission and tested by the laboratory. The Prognostic Nutritional Index (PNI) was subsequently calculated using the formula: PNI = albumin (g/L) + 5 × lymphocyte (109/L). Based on the derived PNI, patients were stratified into two groups: those with a low PNI (PNI < 46.83) and those with a high PNI (PNI ≥ 46.83), utilizing the specified cut-off point. Qualified investigators meticulously monitored all patients at two distinct intervals: 30 days and one-year post-surgery, utilizing either telephonic surveys or medical records for data collection. Furthermore, an exhaustive review was conducted on the comprehensive clinical files of patients who were readmitted or treated as outpatients to identify any adverse events. |
| Intervention type | Other |
| Primary outcome measure | All-cause mortality at (30 days and one year post-surgery) using telephonic surveys or medical records for data collection |
| Secondary outcome measures | Aortic-related adverse events (ARAEs) and major adverse cardiac and cerebrovascular events (MACCEs) at (30 days and one year post-surgery) using telephonic surveys or medical records for data collection |
| Overall study start date | 01/01/2009 |
| Completion date | 01/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 1524 |
| Total final enrolment | 912 |
| Key inclusion criteria | 1. Age range: 18-80 years old 2. Patients with TBAD undergoing TEVAR surgery 3. Complete preoperative albumin, lymphocyte, and other blood test data available 4. No history of aortic surgery 5. No malignant tumor or connective tissue disease |
| Key exclusion criteria | 1. Traumatic or iatrogenic aortic dissection 2. Connective tissue diseases such as: 2.1. Marfan syndrome 2.2. Turner’s syndrome 2.3. Bicuspid aortic valve 2.4. Bechet’s disease 2.5. Ehlers-Danlos syndrome 2.6. Giant cell arteritis 2.7. Ankylosing spondylitis 2.8. Takayasu arteritis 3. Previous aortic surgery 4. History of malignancy 5. Patients with incomplete clinical data |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/07/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200433
China
Sponsor information
Not defined
No.83, Shuangqing Road, Haidian District
Beijing
100085
China
| zhoujian1_3@163.com | |
| Website | http://www.nsfc.gov.cn/publish/portal1/ |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. zhoujian1_3@163.com |
Editorial Notes
24/10/2024: Trial's existence confirmed by Shanghai Changhai Hospital Ethics Committee.
