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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients undergoing ATAAD repair under CPB.

• Age: 18-70 years

• Give consent

Locations
Other Locations
China
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Sanaa Azim
sanaazim@yandex.com
+8615679202116
Backup
Xun Zhang
q172278932@hotmail.com
+8618502522060
Time Frame
Start Date: 2023-12-25
Estimated Completion Date: 2024-08
Participants
Target number of participants: 30
Treatments
ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP
ACP+RIVP under mild to moderate hypothermia
ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP
ACP only under mild to moderate hypothermia.
Related Therapeutic Areas
Sponsors
Leads: The Second Hospital of Nanjing Medical University

This content was sourced from clinicaltrials.gov