Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD

Summary

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).

Conditions

• Type A Aortic Dissection

Interventions

PROCEDURE

Retrograde Inferior Vena Cava Perfusion

Retrograde inferior vena cava (RIVP) involves perfusing oxygenated blood into the inferior vena cava, which then flows towards the viscera, abdominal organs and lower extremities. By maintaining perfusion to these regions during cardiopulmonary bypass (CPB) and induced hypothermia, Retrograde inferior vena cava (RIVP) helps mitigate the risk of ischemic injury to the abdominal organs. Following the initiation of total cardiopulmonary bypass, the body temperature will be gradually lowered to achieve deep-moderate hypothermia ( 24-38°C). This procedure will involve the combination of selective antegrade cerebral perfusion and retrograde inferior vena cava perfusion. Antegrade perfusion will be maintained at a flow rate of 5-7mL/min/kg, while retrograde perfusion will be regulated to sustain the required pumm pressure and blood flow.

PROCEDURE

Antegrade cerebral perfusion

After mild to moderate hypothermia is achieved, a cannula will be inserted into the right axillary artery, brachiocephalic or innominate artery to provide continuous flow to the brain. A flow rate of 5-7mL/min/kg will be maintained.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University

  lead OTHER

Principal Investigators

• Qing Guo Li · The Second Hospital of Nanjing Medical University

• Sanaa Azim · The Second Affiliate Hospital of Nanjing Medical University

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-25

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• China

Study Locations