Type A Aortic Dissection Clinical Trial
Official title:
Impact of Retrograde Inferior Vena Cava Perfusion on Gastrointestinal Function in Patients Undergoing Surgical Repair for Acute Type A Aortic Dissection: A Study Protocol and Prospective Evaluation.
Acute Type A Aortic Dissection (ATAAD) is a serious medical condition that requires immediate surgical intervention. The repair of Acute Type A Aortic Dissection (ATAAD) combines different surgical procedures, including the use of Cardiopulmonary Bypass (CPB). This study focuses on the gastrointestinal (GI) system and the complications arising in the gastrointestinal (GI) system as a result of this procedure. Retrograde Inferior Vena Cava Perfusion (RIVP) is a technique used during Cardiopulmonary Bypass (CPB) that could show potential in mitigating latent gastrointestinal (GI) complications. The study aims to evaluate the effectiveness of Retrograde Inferior Vena Cava Perfusion (RIVP) in patients receiving Acute Type A Aortic Dissection (ATAAD) repair with Cardiopulmonary Bypass (CPB) in reducing Ischemic Reperfusion (IR) injury and inflammatory responses that affect gastrointestinal (GI) integrity. It intends to compare the postoperative gastrointestinal (GI) complications and long-term gastrointestinal (GI) function between patients treated with Antegrade Cerebral Perfusion (ACP) and Retrograde Inferior Vena Cava Perfusion (RIVP), and those treated with Antegrade Cerebral Perfusion (ACP) alone. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionists, and the condition of the patient. Data collection will be facilitated by a comprehensive Case Report Form (CRF). This pilot study, guided by established methodologies, places the study's sample size at 30 to ensure statistical reliability and prevent resource wastage. Through this approach of sample collection, baseline data collection, peri-operative data recording, and follow-up assessments, the study aims to shed light on the impact of Retrograde Inferior Vena Cava Perfusion (RIVP) during Acute Type A Aortic Dissection (ATAAD) repair on gastrointestinal (GI) complications and systemic/intestinal inflammation. The integration of specialized Case Report Forms (CRFs) and structured questionnaires ensures standardized data collection and management, while prioritizing patient confidentiality. The study's data analysis, powered by R software, will provide valuable insights into the efficacy of Retrograde Inferior Vena Cava Perfusion (RIVP) in enhancing clinical outcomes and improving patient's prognosis in the surgical treatment of Acute Type A Aortic Dissection (ATAAD).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients undergoing ATAAD repair under CPB. 2. Age: 18-70 years 3. Give consent Exclusion Criteria: 1. Variables that can influence gut microbiome like antibiotics or probiotics 2 weeks prior to surgery 2. On chemotherapy 3. Evidence of pre-operative malperfusion of the GI system 4. Presence of GI any pathology (IBD,GERD,PU) 5. Continuous enteral feeding prior to surgery 6. Refuse to participate in the study |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
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The Second Hospital of Nanjing Medical University |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RIVP will reduce post operative GI disturbances and gut barrier dysfunction. | Patients undergoing CPB with RIVP may have a better prognosis and less incidence of long term GI disturbance as compared to those patients undergoing CPB without RIVP. Measurement tools: 1. Biomarkers; levels of D-Lactate, FABP2 ( Fatty Acid Binding Protein 2), endotoxins and DAO (Diamine Oxidase). Measurement method: Samples of blood will be analyzed using ELISA ( Enzyme Linked Immunosorbent Assay) | Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7 | |
Primary | Inflammatory response will be possibly reduced in those undergoing RIVP | Measurements: C-Reactive protein (CRP) and 12 cytokine panel. Method: blood samples will be analyzed using immunoassays | Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7 | |
Primary | Gastrointestinal assessment and long term gastrointestinal dysfunction. | Measurement tools: clinical assessment for gastrointestinal function and questionnaire. Special formulated case report forms will contain a detailed questionnaire assessing the quality of life and gastrointestinal function. Method: Baseline gastrointestinal function will be assessed pre opratively and follow up questionnaire post operatively. | Follow up questionaires will be addressed at 1,3,6 and 12 months post hospital discharge. Follow up will be outpatient visits, telephone based calls and interviews, wechat application at the specified intervals |
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